Systems and methods for dispensing a statin medication over the counter

ABSTRACT

A method is provided for treatment of atherosclerotic cardiovascular disease in a subject in need thereof by administering a statin pharmaceutical composition to the subject when the subject is qualified for over-the-counter access to the statin pharmaceutical composition. In some embodiments, the statin pharmaceutical composition includes atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin as an active ingredient.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 16/791,745, filed Feb. 20, 2020, which is a continuation ofU.S. patent application Ser. No. 15/385,747, filed Dec. 20, 2016, andissued as U.S. Pat. No. 10,600,502, each of which are herebyincorporated by reference in their entireties.

TECHNICAL FIELD

The present disclosure relates generally to methods for loweringcholesterol, e.g., thereby treating and/or preventing heart disease, byadministering an over-the-counter statin pharmaceutical composition to asubject in need thereof, who has been qualified for over-the-counteraccess to the composition.

BACKGROUND

Cardiovascular disease remains the leading global cause of death,claiming more lives than all forms of cancer combined. The number ofcardiovascular deaths is expected to increase to approximately 24million annually by 2030. The direct and indirect annual costs totalmore than $316 billion dollars. This exceeds the entire gross domesticproduct (GDP) of all the world's countries except the top 30 countries.

Statins have been a cornerstone therapy for fighting heart disease fornearly three decades. The totality of evidence for reducingcardiovascular disease events is second to none in all of medicine.Statins are still the most prescribed class of medicine.

Despite the fact that many statins will be generically available offpatent in the United States and other markets by 2017, it is expectedthat prevalence of cardiovascular disease will continue. That is, thatheart disease will remain. The next-generation is showing clear signsthey are going to develop cardiovascular disease at high prevalencelevels and need help. Although novel therapies are materializing toaddress cardiovascular disease, it is expected that such novel therapieswill be combined with statins, not replace them. Thus, it is expectedthat statins will remain a cornerstone therapy for cardiovasculardisease for the foreseeable future.

Unfortunately, long-term trends demonstrate many people avoidprescription medications, including statins. One approach to makingstatins more available is to make then available without a prescription,e.g., over the counter (“OTC”). However, because statins cause seriousadverse effects in certain patients, the population receiving the drugshould be carefully selected and monitored. Ramkumar S. et al., ActaCardiol. Sin., 32(6):631-39 (2016). This is why statin distribution hastraditionally been regulated through exclusive prescription access. Inorder to ensure the safety of OTC distribution of statins, prospectivepatients must effectively self-select themselves for the drug. Recentstudies, however, found that many prospective patients do not payconsistent attention to guidelines printed on the packaging of OTCdrugs, to ensure safe and responsible use. PR Newswire Association,“Americans Should Pay More Attention to Over-the-Counter (OTC) medicineLabels According to New Survey”, Oct. 15 (2015) (citing McNeil ConsumerHealthcare research). According to these studies, 40% of prospectivepatients consider the directions as just guidelines and 80% of patientsdo not re-read the label of an OTC medicine they have used before. Evenmore troubling, only 58% of men surveyed found it very important to payattention to restrictions on an OTC label.

Currently, there are two regulatory pathways for legal marketing of anOTC drug in the United States. In the first pathway, marketing occurs incompliance with an OTC drug monograph, that sets regulatory standardsfor non-prescription drugs that are not covered by human drugapplications, e.g., a New Drug Application (NDA) or Abbreviated New DrugApplication (ANDA). An OTC monograph is created as a result of a threephase OTC drug review by the FDA. In phase I of the review, an advisoryreview panel determines whether ingredients in the proposed OTCcomposition could be generally recognized as safe and effective for usein self-treatment. In the second pathway, marketing occurs under theauthority of an approved product-specific new drug application (NDA), oran abbreviated new drug application (ANDA). In order to support anover-the-counter label for a drug for which regulatory approval is beingsought through an NDA, a consumer research study is required to assessthe consumer's ability to select and deselect themselves as appropriateusers of the drug, based on the proposed labeling for the drug. Oliver,A., Regulatory Rapporteur, 10(3):4-9 (2013), which is incorporated byreference herein.

However, attempts at switching distribution of cardiovascular drugshaving potentially far-reaching benefits for societal health, fromprescription-only to an OTC model, have repeatedly failed, in large partdue to concerns over inappropriate patient selection and medication.Possibly the best documented cases relate to statins used to treat highcholesterol.

For instance, Merck has had at least three applications for sale of overthe counter lovastatin rejected by the FDA, in 2000, 2005, and 2007. In2005, their proposal to permit over the counter sales of lovastatin wasrejected by an expert advisory panel at the FDA in 2005. The panel wasconcerned by a marketing study performed to support the proposal inwhich approximately one third of 3316 customers who were offered thedrug over the counter decided they would purchase the drug. Afterreviewing the data, the panel concluded that 45% of the purchases wouldhave been inappropriate for a variety of reasons, including the age ofthe subject, the subject's lack of knowledge about their condition, andcontraindications associated with their condition. Dyer O., BMJ,330(7484):164 (2005). In 2007, the board again concluded that theability of consumers to appropriately self-select and to adequatelycomply with chronic MEVACOR® therapy without the intervention of aphysician had not been demonstrated. Division of Metabolic and EndocrineDrug Products, 2005, “NDA 21-213 Non-prescription MEVACOR® 20 mg JointAdvisory Committee Meeting.”

Similarly, Pfizer announced in 2011 its intention to switch LIPITOR®from prescription-only to OTC status. Sett OTC bulletin, 16 Nov. 2011,page 7. However, they abandoned their attempt in 2014 when a phase 3“actual use” trial, intended to simulate the OTC use of LIPITOR®(atorvastatin calcium) 10 mg, failed to meet its primary objectives onthe basis that patient compliance with the direction to check theirlow-density lipoprotein cholesterol (LDL-C) level and, after checkingtheir LDL-C level, take appropriate action based on their test resultswas unsatisfactory. Pfizer Inc., “Pfizer Reports Second-Quarter 2015Results,” (2015).

In fact, in the nearly two decades since Bristol-Myers Squibb and Merck& Co first failed in their attempts to switch PRAVACHOL® and lovastatin,respectively, to OTC, a statin has never been granted OTC status in theUnited States. This is despite that nearly 40 million adults in the U.S.who are eligible for cholesterol-lowering medications, under the currentguidelines, are not taking anything.

The information disclosed in this Background section is only forenhancement of understanding of the general background of the inventionand should not be taken as an acknowledgment or any form of suggestionthat this information forms the prior art already known to a personskilled in the art.

SUMMARY

Given the above background, systems and methods are needed forqualifying a human subject for delivery of a statin pharmaceuticalcomposition over-the-counter to lower cholesterol, e.g., thereby,treating or preventing heart disease.

The present disclosure addresses the need in the art for systems andmethods configured for qualifying a human subject for anover-the-counter provision of a statin pharmaceutical composition (e.g.,a rosuvastatin pharmaceutical composition such as rosuvastatin calcium)in order to treat or prevent heart disease, e.g., by loweringcholesterol. In the present disclosure, systems and methods are providedfor an over-the-counter provision of a statin pharmaceutical compositionto a subject. An information set is obtained from the subject andapplied to an algorithm. The algorithm runs the information set againsta first plurality of filters. When a filter in the first plurality isfired, the subject is deemed not qualified for a statin treatment. Thealgorithm also runs the information set against a second plurality offilters. When a respective filter in the second plurality is fired, thesubject is provided with a corresponding warning. The method proceeds toa fulfillment process when no filter in the first plurality is fired andthe subject has acknowledged each warning associated with each firedfilter in the second plurality of filters. The fulfillment processstores the composition order, communicates a drug facts label for thestatin pharmaceutical composition to the subject, and authorizes, uponsubject confirmation that the label has been read, provision of thestatin pharmaceutical composition to the subject.

Accordingly, one aspect of the present disclosure provides a method forqualifying a subject for an over-the-counter provision of a statinpharmaceutical composition. The method includes providing an assessmentsurvey of the subject in order to obtain a first information set. Insome embodiments, the first information set include one or more of: asex of the subject, an age of the subject, when the subject isfemale—whether the subject is pregnant or breastfeeding, whether thesubject is taking one or more compositions that interact (e.g., via apharmacokinetic interaction and/or a pharmacodynamic interaction) withthe statin pharmaceutical composition, whether the subject has ever hada cardiac event, a cholesterol level of the subject (e.g., a totalcholesterol level, a LDL cholesterol level, and a HDL cholesterollevel), a triglyceride level of the subject, a blood pressure of thesubject (e.g., a systolic blood pressure of the subject and/or adiastolic blood pressure of the subject), whether the subject has aliver condition, an alcohol consumption status of the subject, andwhether the subject has had an adverse reaction to acholesterol-lowering composition.

The method also includes applying an algorithm to the first informationset. The algorithm runs all or a portion of the first information setagainst a first plurality of assessment filters. When a respectivefilter in the first plurality of assessment filters is fired, thesubject is deemed not qualified for a statin treatment. The method isthen terminated accordingly without authorizing provision of the statinpharmaceutical composition to the subject. In some embodiments, thefirst plurality of assessment filters includes one or more of an agefilter, a pregnancy filter, a severe drug interaction filter, a cardiacevent filter, a total cholesterol filter, a HDL cholesterol filter, aLDL cholesterol filter, a triglyceride level filter, a blood pressurefilter, an atherosclerotic cardiovascular disease (ASCVD) risk pooledcohort equation filter, and a liver condition filter.

The algorithm also runs all or a portion of the first information setagainst a second plurality of assessment filters. When a respectivefilter in the second plurality of assessment filters is fired, thesubject is provided with a warning corresponding to the respectivefilter. In some embodiments, the second plurality of assessment filtersincludes one or more of an alcohol consumption filter, a first adversereaction filter, and a moderate drug interaction filter. However, unlikefilters in the first plurality of assessment filters, filters in thesecond plurality of assessment filters do not automatically terminatethe process without provision of the statin pharmaceutical compositionto the subject.

The method continues by obtaining acknowledgment from the subject forthe warning issued to the subject by any filter in the second pluralityof assessment filters. In some embodiments, acknowledgment from thesubject is a written acknowledgement, a verbal acknowledgment, or anelectronic acknowledgment such as an electronic signature.

The method continues by proceeding with a fulfillment process when nofilter in the first plurality of filters has been fired and the subjecthas acknowledged each warning associated with each filter in the secondplurality of filters that was fired.

In some embodiments, the fulfillment process includes storing anindication in a subject profile of an initial order for the statinpharmaceutical composition, communicating an over-the-counter drug labelfor the statin pharmaceutical composition, and authorizing, uponconfirmation from the subject that the over-the-counter drug label hasbeen received and read, provision of the statin pharmaceuticalcomposition to the subject.

In some embodiments, the statin pharmaceutical composition includes anactive ingredient of rosuvastatin or a pharmaceutically acceptable saltthereof (e.g., rosuvastatin calcium, etc.) In some embodiments, thestatin pharmaceutical composition includes an active ingredient ofrosuvastatin calcium. In some embodiments, the statin pharmaceuticalcomposition includes an active ingredient selected from the groupconsisting of atorvastatin, fluvastatin, lovastatin, pitavastatin,pravastatin, and simvastatin as an active ingredient.

In one aspect, the present disclosure provides a method forre-qualifying a subject for an over-the-counter provision (e.g., asubject who was previously qualified to receive a provision of thestatin pharmaceutical composition) of the statin pharmaceuticalcomposition (e.g., which is optionally performed in conjunction with amethod for qualifying the subject for an initial order of the statinpharmaceutical composition). The method includes providing are-assessment survey of the subject in order to obtain a secondinformation set. In some embodiments, the second information setincludes one or more of whether the subject has had a documented cardiacevent since receiving their last provision of the statin pharmaceuticalcomposition, when the subject is female—whether the subject is pregnantor breastfeeding, whether the subject is taking one or more compositionsthat interact with the statin pharmaceutical composition, whether thesubject has experienced liver problems since receiving their lastprovision of the statin pharmaceutical composition, whether the subjecthas experienced a muscle irregularity since receiving their lastprovision of the statin pharmaceutical composition, and an alcoholconsumption status of the subject.

The method also includes applying an algorithm to the second informationset. The algorithm runs all or a portion of the second information setagainst a first plurality of re-assessment filters. When a respectivefilter in the first plurality of re-assessment filters is fired, thesubject is deemed not qualified for a statin treatment. Accordingly, themethod is terminated without authorizing re-provision of the statinpharmaceutical composition to the subject. In some embodiments, thefirst plurality of re-assessment filters includes one or more of acardiac event filter, a cholesterol status filter, when the subject isfemale—a pregnancy filter, a severe drug interaction filter, a livercondition filter, and a muscle irregularity filter.

The algorithm also runs all or a portion of the second information setagainst a second plurality of re-assessment filters. When a respectivefilter in the second plurality of re-assessment filters is fired, thesubject is provided with a warning corresponding to the respectivefilter. In some embodiments, the second plurality of re-assessmentfilters includes one or more of an alcohol consumption filter and amoderate drug interaction filter.

In some embodiments, the method includes storing an indication in thesubject profile of a re-order for the statin pharmaceutical composition,communicating an over-the-counter drug facts label for the statinpharmaceutical composition to the subject, and authorizing, uponconfirmation from the subject that the over-the-counter drug facts labelhas been received and read, re-provision of the statin pharmaceuticalcomposition to the subject.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary system topology that includes a statinpharmaceutical composition over-the-counter (OTC) dispensing device forqualifying a human subject for an over-the-counter provision of a statinpharmaceutical composition to lower cholesterol, a data collectiondevice for collecting subject data, one or more user devices associatedwith human subjects, and one or more dispensary destinations fordistributing the statin pharmaceutical composition over-the-counter,where the above-identified components are interconnected, optionallythrough a communications network, in accordance with various embodimentsof the present disclosure.

FIG. 2 illustrates an example device for qualifying a human subject fora provision of a statin pharmaceutical composition over-the-counter tolower cholesterol in accordance with various embodiments of the presentdisclosure.

FIGS. 3A and 3B collectively illustrate an example device associatedwith a human subject for qualifying the human subject for anover-the-counter provision of a statin pharmaceutical composition forlowering cholesterol, e.g., thereby treating and/or preventing heartdisease, in accordance with various embodiments of the presentdisclosure. In some embodiments, the example device of FIGS. 3A and 3Bworks in conjunction with the device of FIG. 2 to perform the methodsillustrated in FIGS. 4, 5, 8, and 9 in some embodiments by, forinstance, providing the device of FIG. 2 with information sets and/orthe results of firing filters of the present disclosure against suchinformation sets. In some embodiments, the device of FIG. 2 performs allthe methods of the present disclosure and the device of FIGS. 3A and 3Bis not used. In other embodiments, the device of FIGS. 3A and 3Bperforms the methods of the present disclosure and the device of FIG. 2is not used.

FIGS. 4A, 4B, 4C, 4D, 4E, 4F, 4G, 4H, 4I, 4J, 4K, 4L, and 4Mcollectively provide a flow chart of processes for qualifying a humansubject for an over-the-counter provision of a statin pharmaceuticalcomposition to lower cholesterol, in accordance with various embodimentsof the present disclosure.

FIGS. 5A, 5B, 5C, 5D, 5E, 5F, and 5G collectively provide a flow chartof processes for re-qualifying a human subject for an over-the-counterprovision of a statin pharmaceutical composition to lower cholesterol,in accordance with various embodiments of the present disclosure.

FIGS. 6A, 6B, 6C, and 6D illustrate example prompts and informationassociated with assessment and/or reassessment filters of a first type(FIGS. 6A and 6B) and filters of a second type (FIGS. 6C and 6D), inaccordance with various embodiments of the present disclosure.

FIG. 7 illustrates feedback from a portion of an assessment survey, inaccordance with various embodiments of the present disclosure.

FIGS. 8A, 8B, 8C, 8D, 8E, 8F, 8H, 8H, and 8I collectively illustrate anexample method for qualifying a subject for an over-the-counterprovision of a statin pharmaceutical composition, in accordance withvarious embodiments of the present disclosure.

FIGS. 9A, 9B, 9C, and 9D collectively illustrate an example method forre-qualifying a subject for an over-the-counter provision of a statinpharmaceutical composition, in accordance with various embodiments ofthe present disclosure.

FIG. 10 illustrates example statins in accordance with the prior art.

In the figures, reference numbers refer to the same or equivalent partsof the present invention throughout the several figures of the drawing.

DETAILED DESCRIPTION

Hypercholesterolemia is a growing health problem, in the United Statesand worldwide. Although hypercholesterolemia can be effectively treatedand/or prevented using established pharmaceutical compositions, accessto these drugs is hindered by to the requirement for a prescription, asmany individuals do not have adequate access and/or avoid the healthcaresystem for a variety of reasons. Accordingly, many people are notmanaging their hypercholesterolemia or conditions related tohypercholesterolemia appropriately. While over-the-counter alternativesto these prescription pharmaceuticals would increase access to thesecompositions, thereby improving population management ofhypercholesterolemia and conditions related to hypercholesterolemiaaround the world, patients often have difficulty self-selectingthemselves for an appropriate over-the-counter medication. Becauseinappropriate use of these drugs can result in ineffective treatmentand/or serious side-effects, better systems and methods for selectingfor, and treating patients with, other-the-counter hypercholesterolemiamedications are needed. The present disclosure provides, among otheraspects, methods, systems, and computer readable media that solve theseproblems.

Reference will now be made in detail to implementations, examples ofwhich are illustrated in the accompanying drawings. In the followingdetailed description of implementations, numerous specific details areset forth in order to provide a thorough understanding of the presentinvention. However, it will be apparent to one of ordinary skill in theart that the present invention may be practiced without these specificdetails.

It will also be understood that, although the terms first, second, etc.may be used herein to describe various elements, these elements shouldnot be limited by these terms. These terms are only used to distinguishone element from another. For example, a first filter could be termed asecond filter, and, similarly, a second filter could be termed a firstfilter, without departing from the scope of the present disclosure. Thefirst filter and the second filter are both filters, but they are notthe same filter.

The terminology used in the present disclosure is for the purpose ofdescribing particular embodiments only and is not intended to belimiting of the invention. As used in the description of the inventionand the appended claims, the singular forms “a,” “an,” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will also be understood that the term “and/or”as used herein refers to and encompasses any and all possiblecombinations of one or more of the associated listed items. It will befurther understood that the terms “comprises” and/or “comprising,” whenused in this specification, specify the presence of stated features,integers, steps, operations, elements, and/or components, but do notpreclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof.

As used herein, the term “if” may be construed to mean “when” or “upon”or “in response to determining” or “in response to detecting,” dependingon the context. Similarly, the phrase “if it is determined” or “if [astated condition or event] is detected” may be construed to mean “upondetermining” or “in response to determining” or “upon detecting [thestated condition or event]” or “in response to detecting [the statedcondition or event],” depending on the context.

As used herein, the term “over-the-counter” means to provide by retailpurchase, subject to the constraints disclosed herein, but without aprescription or license from a physician or medical practitioner.

As used herein, the term “pharmaceutical compound” refers to anyphysical state of a material. Pharmaceutical compounds include but arenot limited to capsules, tablets, liquids, topical formulations, andinhaled formulations.

As used herein, the term “contraindication” refers to a condition thatmakes a treatment, e.g., over-the-counter use of a statin pharmaceuticalcomposition, inadvisable. Contraindications include physicalcharacteristics of a subject, e.g., pregnancy or liver conditions, andcontemporaneous drug use, e.g., statin pharmaceutical composition use.In the present context, identification of a contraindication fires afilter in a first plurality of filters, which prevents authorizingprovision of a statin pharmaceutical composition, in accordance withsome implementations of the methods, systems, and software disclosedherein.

As used herein, the term “risk factor” refers to a condition that makesa treatment, e.g., over-the-counter use of a statin pharmaceuticalcomposition, possibly inadvisable. Risk factors include physicalcharacteristics of a subject, e.g., a blood pressure reading, andcontemporaneous drug use, e.g., use of a cholesterol-loweringcomposition. In the present context, identification of a risk factorfires a filter in a second plurality of filters, which preventsauthorizing provision of a statin pharmaceutical composition withoutconfirmation that the subject has discussed the risk factor with amedical professional, in accordance with some implementations of themethods, systems, and software disclosed herein.

As used herein, “drug interactions,” e.g., with a statin pharmaceuticalcomposition, include pharmacokinetic drug interactions andpharmacodynamics drug interactions. Generally, a pharmacokinetic druginteraction is an interaction between two drugs (e.g., a statin and asecond drug) that result in alterations in the absorption, transport,distribution, metabolism, and/or excretion of either drug. Generally, apharmacokinetic drug interaction is an interaction between two drugs(e.g., a statin and a second drug) that result in a direct change in theeffect or either drug. For a more comprehensive summary ofpharmacokinetic drug interactions and pharmacodynamics druginteractions, see, Cascorbi, I, Dtsch Arztebl Int., 109(33-34):546-55(2012), the content of which is hereby incorporated by reference.

In the context of the present disclosure, classification of a conditionas either a contraindication or a risk factor is specific to aparticular identity and dose of a statin pharmaceutical compositionbeing authorized for over-the-counter use. Classification of aparticular condition, e.g., contemporaneous statin pharmaceuticalcomposition use, may vary between different statin pharmaceuticalcompositions (e.g., it may be classified as a contraindication for afirst statin, a risk factor for a second statin, and/or neither for athird statin). Likewise, a particular condition may be classified as acontraindication for use of a particular statin at a firstover-the-counter dosage, classified as a risk factor for the sameparticular statin at a second (e.g., lower) over-the-counter dosage,and/or classified as neither for the same particular statin at a third(e.g., lowest) over-the-counter dosage.

As used herein, whether a subject “has developed” and/or “hasexperienced” a condition since receiving their last provision of astatin pharmaceutical composition refers to both conditions that are newto the subject, i.e., a condition that the subject did not have at thetime they received their last provision of the statin pharmaceuticalcomposition, and conditions that have been newly diagnosed, regardlessof whether the condition existed when the subject received their lastprovision of the statin pharmaceutical composition, e.g., a conditionthat the subject was not aware of when they received their lastprovision of the statin pharmaceutical composition.

The term “salt(s)” includes salts of the compounds prepared by theneutralization of acids or bases, depending on the particular ligands orsubstituents found on the compounds described herein. When compounds ofthe present disclosure contain relatively acidic functionalities, baseaddition salts can be obtained by contacting the neutral form of suchcompounds with a sufficient amount of the desired base, either neat orin a suitable inert solvent. Examples of base addition salts includesodium, potassium calcium, ammonium, organic amino, or magnesium salt,or a similar salt. Examples of acid addition salts include those derivedfrom inorganic acids like hydrochloric, hydrobromic, nitric, carbonic,monohydrogencarbonic, phosphoric, monohydrogenphosphoric,dihydrogenphosphoric, sulfuric, monohydrogensulfuric, hydriodic, orphosphorous acids, and the like, as well as the salts derived fromrelatively nontoxic organic acids like acetic, propionic, isobutyric,butyric, maleic, malic, malonic, benzoic, succinic, suberic, fumaric,lactic, mandelic, phthalic, benzenesulfonic, p-tolylsulfonic, citric,tartaric, methanesulfonic, and the like. Certain specific compounds ofthe present invention contain both basic and acidic functionalities thatallow the compounds to be converted into either base or acid additionsalts. Hydrates of the salts are also included.

In one aspect of the present disclosure, a survey (e.g., an assessmentsurvey and/or a re-assessment survey) of a subject is provided to obtainan information set in order to determine if the subject qualifies for anover-the-counter (OTC) provision of a statin pharmaceutical compositionfor lowering cholesterol, e.g., thereby, treating or preventing anatherosclerotic cardiovascular disease. The information set is used asthe basis for running filters in a first plurality of filters. If thetriggering conditions of any of the filters in the first plurality offilters are fired, the subject does not qualify for the OTC statinpharmaceutical composition. In some embodiments, the information set isalso used as the basis for running filters of a second plurality offilters. If the triggering conditions of any of the filters in thesecond plurality of filters are fired, the subject is provided withwarning messages associated with the respective filters of the secondplurality of filters that have been fired. If none of the filters in thefirst plurality of filters are fired and the subject successfullyaddresses the warning messages associated with the respective filters ofthe second plurality of filters that have been fired a fulfillmentprocess is initiated for an OTC provision of the statin pharmaceuticalcomposition.

FIG. 1 illustrates an example of an integrated system 48 for providingone or more surveys (e.g., an assessment survey and/or a re-assessmentsurvey) of one or more subjects in order to qualifying the subjects foran OTC provision of a statin pharmaceutical composition. The integratedsystem 48 includes one or more connected user devices 102 (e.g., firstuser device 102-1, second user device 102-2, . . . , Q^(th) user device102-Q). The user devices 102 are configured for entering survey data andmaking requests for the statin pharmaceutical composition. The system 48also includes one or more dispensary destination devices 104 that areconfigured to receive instructions in order to provide the statinpharmaceutical composition to qualifying subjects. Furthermore, thesystem 48 includes a statin pharmaceutical composition over-the-counter(OTC) dispensing device 250 and one or more data collection devices 200that are configured for collecting subject data.

Throughout the present disclosure, the data collection device 200 andthe statin pharmaceutical composition OTC dispensing device 250 will bereferenced as separate devices solely for purposes of clarity. That is,the disclosed functionality of the data collection device 200 and thedisclosed functionality of the statin pharmaceutical composition OTCdispensing device 250 are contained in separate devices as illustratedin FIG. 1. However, it will be appreciated that, in fact, in someembodiments, the disclosed functionality of the data collection device200 and the disclosed functionality of the statin pharmaceuticalcomposition OTC dispensing device 250 are contained in a single device.

With the integrated system 48, information sets obtained from thesubjects are run against a first plurality of filters, such as a firstplurality of assessment filters (e.g., filter 216-1, filter 216-2,filter 216-11, etc.) and/or a first plurality of re-assessment filters(e.g., filter 216-12, filter 216-17, etc.). When a filter in therespective first plurality of filters (e.g., filter 216) is fired for arespective subject, the respective subject is deemed not qualified forthe statin pharmaceutical composition. In some embodiments, theinformation set is also run against a second plurality of filters (e.g.,filter 222-1, filter 222-2, filter 222-4, etc.) and/or a secondplurality of re-assessment filters (e.g., filter 222-4, filter 222-5,etc.). When a respective filter in the respective second plurality isfired for a respective subject, the respective subject is provided witha warning (e.g., filter warning 226) associated with the respectivefilter. In some embodiments, the information set is run against thefirst plurality of filters and the second plurality of filtersconcurrently. In some embodiments, the information set is run againstthe first plurality of filters and then against the second plurality offilters (e.g., sequentially). For instance, in some embodiments theinformation set is obtained and then run against the plurality offilters. However, the present disclosure is not limited thereto. In someembodiments, each piece of information of the information set is runagainst a corresponding filter prior to a subsequent piece ofinformation of the information set being obtained. This running prior tothe subsequent piece prevents a user from unnecessarily providing apiece of information in accordance with a determination that the user isnot qualified for the statin pharmaceutical composition (e.g., preservesprivacy of a subject).

As used herein, unless expressly stated otherwise, a survey refers toboth an assessment survey and/or a re-assessment survey. For instance,in some embodiments a first survey result corresponds to an assessmentsurvey (e.g., a piece of information of a first information set),whereas in other embodiments a first survey results corresponds to are-assessment survey(e.g., a piece of information of a secondinformation set), without departing from the scope of the presentdisclosure.

The method enabled by the integrated system 48 proceeds to a fulfillmentprocess, or similarly a re-fulfillment process, when no filter in therespective first plurality of filters fires and the subject hasacknowledged, or otherwise successfully addressed, each warningassociated with each filter in the respective second plurality offilters that fired. As part of the fulfillment process, orre-fulfillment process, the composition order is stored (e.g., in a userprofile 234 associated with the subject to receive the pharmaceuticalcomposition), a drug facts label (e.g., drug facts label 230) for thestatin pharmaceutical composition is communicated to the qualifyingsubject. Upon subject confirmation that the label has been read,authorization is granted to provide a provision of the statinpharmaceutical composition.

Referring to FIG. 1, the statin pharmaceutical composition OTCdispensing device 250 qualifies a subject for an over-the-counterprovision of a statin pharmaceutical composition to lower cholesterol.To accomplish the above, the data collection device 200, which is inelectrical communication with the statin pharmaceutical composition OTCdispensing device 250, receives an information set (e.g., a firstinformation set associated with an assessment survey and/or a secondinformation set associated with a re-assessment survey) originating fromone or more user devices 102 that are associated with correspondingsubjects. In some embodiments, the data collection device 200 receivesthe respective information sets directly from the user devices 102. Forinstance, in some embodiments the data collection device 200 receivesthis data wirelessly through radio-frequency (RF) signals. In someembodiments, such signals are in accordance with an 802.11 (Wi-Fi),Bluetooth, or ZigBee standard. In some embodiments, the data collectiondevice 200 receives such data directly, analyzes the data, and passesthe analyzed data to statin pharmaceutical composition OTC dispensingdevice 250.

In some embodiments, the data collection device 200 and/or the statinpharmaceutical composition OTC dispensing device 250 is not proximate tothe subject and/or does not have wireless capabilities or such wirelesscapabilities are not used for the purpose of acquiring survey results.In such embodiments, a communication network 106 may be used tocommunicate survey questions (e.g., survey questions 208, 212) from thestatin pharmaceutical composition OTC dispensing device 250 to userdevices 102 and the answers (e.g., the respective information set) tosuch survey questions from the user devices 102 to the data collectiondevice 200 and/or the statin pharmaceutical composition OTC dispensingdevice 250. Further, in some embodiments the communication network 106communicates authorization to dispense the statin survey questions fromthe statin pharmaceutical composition OTC dispensing device 250 todispensary destination devices 104.

Examples of networks 106 include, but are not limited to, the World WideWeb (WWW), an intranet and/or a wireless network, such as a cellulartelephone network, a wireless local area network (LAN) and/or ametropolitan area network (MAN), and other devices by wirelesscommunication. The wireless communication optionally uses any of aplurality of communications standards, protocols and technologies,including but not limited to Global System for Mobile Communications(GSM), Enhanced Data GSM Environment (EDGE), high-speed downlink packetaccess (HSDPA), high-speed uplink packet access (HSUPA), Evolution,Data-Only (EV-DO), HSPA, HSPA+, Dual-Cell HSPA (DC-HSPDA), long termevolution (LTE), near field communication (NFC), wideband code divisionmultiple access (W-CDMA), code division multiple access (CDMA), timedivision multiple access (TDMA), Bluetooth, Wireless Fidelity (Wi-Fi)(e.g., IEEE 802.11a, IEEE 802.11ac, IEEE 802.11ax, IEEE 802.11b, IEEE802.11g and/or IEEE 802.11n), voice over Internet Protocol (VoW),Wi-MAX, a protocol for e-mail (e.g., Internet message access protocol(IMAP) and/or post office protocol (POP)), instant messaging (e.g.,extensible messaging and presence protocol (XMPP), Session InitiationProtocol for Instant Messaging and Presence Leveraging Extensions(SIMPLE), Instant Messaging and Presence Service (IMPS)), and/or ShortMessage Service (SMS), or any other suitable communication protocol,including communication protocols not yet developed as of the filingdate of the present disclosure.

Of course, other topologies of the system 48 are possible. For instance,rather than relying on a communications network 106, the one or moreuser devices 102 and the one or more dispensary destination devices 104may communicate directly to the data collection device 200 and/or thestatin pharmaceutical composition OTC dispensing device 250. Further,the data collection device 200 and/or the statin pharmaceuticalcomposition OTC dispensing device 250 may constitute a portableelectronic device, a server computer, or in fact constitute severalcomputers that are linked together in a network, be a virtual machine ina cloud computing context, be a container in a cloud computer context,or a combination thereof. As such, the exemplary topology shown in FIG.1 merely serves to describe the features of an embodiment of the presentdisclosure in a manner that will be readily understood to one of skillin the art.

Turning to FIG. 2 with the foregoing in mind, an exemplary statinpharmaceutical composition OTC dispensing device 250 configured fordetermining whether a subject is qualified for an OTC provision of astatin pharmaceutical composition is depicted. Referring to FIG. 2, intypical embodiments, the statin pharmaceutical composition OTCdispensing device 250 includes one or more computers. For purposes ofillustration in FIG. 2, the statin pharmaceutical composition OTCdispensing device 250 is represented as a single computer that includesall of the functionality for qualifying a human subject for anover-the-counter provision of a statin pharmaceutical composition tolower cholesterol. However, the present disclosure is not limitedthereto. In some embodiments, the functionality for qualifying a humansubject for an over-the-counter provision of a statin pharmaceuticalcomposition to lower cholesterol is spread across any number ofnetworked computers and/or resides on each of several networkedcomputers, is hosted on one or more virtual machines at a remotelocation accessible across the communications network 106, and/or ishosted on one or more containers at a remote location accessible acrossthe communications network 106. One of skill in the art will appreciatethat any of a wide array of different computer topologies are used forthe present disclosure and all such topologies are within the scope ofthe present disclosure.

The statin pharmaceutical composition OTC dispensing device 250 of FIG.2 is configured to conduct an assessment survey (e.g., using assessmentmodule 252 to perform an initial qualification of the subject for aprovision of a statin pharmaceutical composition) and/or a re-assessmentsurvey (e.g., using re-assessment module 254 to perform are-qualification of the subject for provision of a statin pharmaceuticalcomposition). The assessment survey (e.g., the assessment) includes avariety of questions 208, 212 associated with assessment filters 216,222 within a first plurality of assessment filters (e.g., filters 214)and a second plurality of assessment filters (e.g., filters 220),respectively. An algorithm is used to run answers to the questions inthe assessment survey (e.g., a first information set) received by thedevice 250 against one or more assessment filters 216 in the firstplurality of assessment filters 214-1 and/or, in some embodiments, oneor more assessment filters 222 in the second plurality of assessmentfilters 220-1, respectively. Similarly, the re-assessment survey (e.g.,the re-assessment) also includes a variety of questions 208, 212associated with one or more re-assessment filters 216 in the firstplurality of re-assessment filters 214-2 and/or, in some embodiments,one or more re-assessment filters 222 in the second plurality ofre-assessment filters 220-2, respectively. Answers to the questions inthe re-assessment survey (e.g., a second information set) received bythe device 250 are run against one or more re-assessment filters in afirst plurality of re-assessment filters 216-2 and re-assessment filtersin a second plurality of re-assessment filters 220-2, e.g., within thefirst and second pluralities of re-assessment filters, respectively.Re-assessment filters 216 of the first plurality of re-assessmentfilters 214-2 are configured to terminate the re-qualification processwhen fired. Re-assessment filters 222 of the second plurality ofre-assessment filters 220-2 are configured to provide the subject with awarning associated with a corresponding survey question. In other words,the device of FIG. 2 is configured to accumulate results (e.g., aninformation set) from a survey (e.g., survey questions 208 and surveyquestions 212 of an assessment survey module 252 and/or a re-assessmentsurvey module 545) and apply an algorithm to the results by running theresults against corresponding filters (e.g., assessment filters and/orre-assessment filters, respectively) in order to determine if a subjectis qualified for an OTC provision of a statin pharmaceuticalcomposition.

In the present disclosure, a plurality of filters refers to a series, orset, or filters in either the first plurality of filters or the secondplurality of filters of a respective survey. For instance, in someembodiments, a plurality of filters of the first plurality of filters214 can include any subset of filters 216 of the first plurality offilters (e.g., any subset of filters of the first plurality ofassessment filters and the first plurality of re-assessment filters). Asan example, in some embodiments a plurality of filters of the firstplurality of filters includes filters 216-1, 216-2, 216-3, . . . ,216-i, or any combination thereof. Similarly, a plurality of filters ofthe second plurality of filters 220 can include any set of filters 222of the second plurality of filters (e.g., any subset of filters of thesecond plurality of assessment filters and the second plurality ofre-assessment filters). Moreover, in some embodiments a plurality offilters of the second plurality of filters includes filters 222-1,222-2, 222-3, . . . , 222-i, or any combination thereof. However, thepresent disclosure is not limited thereto. For instance, in someembodiments filters of the first plurality of filters are categorizedaccording to which survey the filter is associated with (e.g., the firstplurality of filters is categorized by assessment filters and/orre-assessment filters, the second plurality of filters is categorized byassessment filters and/or re-assessment filters).

Continuing to refer to FIG. 2, in some embodiments, the dispensingdevice 250 includes one or more processing units (CPU's) 274, a networkor other communications interface 284, a memory 192 (e.g., random accessmemory), one or more magnetic disk storage and/or persistent devices 290optionally accessed by one or more controllers 288, one or morecommunication busses 213 for interconnecting the aforementionedcomponents, a user interface 278, the user interface 278 including adisplay 282 and input 280 (e.g., a keyboard, a keypad, a touch screen,etc.), and a power supply 276 for powering the aforementionedcomponents. In some embodiments, data in memory 192 is seamlessly sharedwith non-volatile memory 290 using known computing techniques such ascaching. In some embodiments, memory 192 and/or memory 290 includes massstorage that is remotely located with respect to the central processingunit(s) 274. In other words, some data stored in memory 192 and/ormemory 290 may in fact be hosted on computers that are external to thestatin pharmaceutical composition OTC dispensing device 250 but that canbe electronically accessed by the statin pharmaceutical composition OTCdispensing device 250 over an Internet, intranet, or other form ofnetwork or electronic cable (illustrated as element 106 in FIG. 2) usingnetwork interface 284.

In some embodiments, the memory 192 of the statin pharmaceuticalcomposition OTC dispensing device 250 stores one or more of:

-   -   an operating system 202 that includes procedures for handling        various basic system services;    -   an assessment module 252 for qualifying a subject for an initial        over-the-counter provision of a statin pharmaceutical        composition to lower cholesterol, e.g., treating or preventing        heart disease, by communicating assessment survey questions,        obtaining results therefrom, and utilizing an algorithm to apply        the results to qualifying assessment filters, the assessment        module including:        -   a first plurality of assessment filters 214-1, including            assessment filters 216, each respective assessment filter            216 in the first plurality of assessment filters 214-1            associated with one or more assessment survey questions 208            and one or more triggering conditions 218;        -   a second plurality of assessment filters 220-1, including            assessment filters 222, each respective assessment filter            222 in the second plurality of assessment filters 220-1            associated with one or more assessment survey questions 208,            triggering conditions 224, and warnings 226;    -   a fulfillment module 228-1 for executing a fulfillment process        when no assessment filter 216 in the first plurality of        assessment filters 214-1 has been fired for a subject and the        subject has acknowledged each warning 226 associated with each        assessment filter 222 in the second plurality of assessment        filters 220-1 that was fired as a result of answers by the        subject to the assessment survey questions 208, where the        fulfillment process includes communicating an over-the-counter        drug facts label 230 for the statin pharmaceutical composition        to the subject and receiving confirmation from the subject that        the over-the-counter drug facts label has been received and        read;    -   a re-assessment module 254 for re-qualifying a subject for an        over-the-counter provision of a statin pharmaceutical        composition to lower cholesterol, e.g., treating or preventing        heart disease, by communicating re-assessment survey questions,        obtaining results therefrom, and utilizing an algorithm to apply        the results to qualifying re-assessment filters, the        re-assessment module including:        -   a first plurality of re-assessment filters 214-2, including            re-assessment filters 216, each respective re-assessment            filter 216 in the first plurality of re-assessment filters            214-2 is associated with one or more re-assessment survey            questions 208 and one or more triggering conditions 218;        -   a second plurality of re-assessment filters 220-2, including            re-assessment filters 222, each respective filter 222 in the            second plurality of re-assessment filters 220-2 is            associated with one or more survey questions 212, triggering            conditions 224, and warnings 226;    -   a re-fulfillment module 228-2 for executing a re-fulfillment        process when no re-assessment filter 216 in the first plurality        of re-assessment filters 214-2 has been fired for a subject and        the subject has acknowledged each warning 226 associated with        each re-assessment filter 222 in the second plurality of        re-assessment filters 220-2 that was fired as a result of        answers by the subject to the re-assessment survey questions        212, where the re-fulfillment process includes communicating an        over-the-counter drug facts label 230 for the statin        pharmaceutical composition to the subject and receiving        confirmation from the subject that the over-the-counter drug        facts label has been received and read;    -   a subject profile data store 232 including a user profile 234        for each of a plurality of subjects, each respective user        profile 234 including information (e.g., shipping information,        billing information, biometric information, etc.) about a        corresponding subject in the plurality of subjects, an initial        order date (e.g., an initial date for qualifying for a provision        of a statin pharmaceutical composition) and/or destination 236,        and any re-order date (e.g., a date for re-qualifying for a        provision of a statin pharmaceutical composition) and/or the        destination 238 for the statin pharmaceutical composition made        by the corresponding subject using the statin pharmaceutical        composition OTC dispensing device 250;    -   an adverse event module 242 for identifying and aggregating        records of adverse events associated with a plurality of        subjects, e.g., corresponding to the firing of a re-assessment        filter 216 in the first plurality of re-assessment filters 214-2        during a re-fulfillment process;    -   a reimbursement module 240 for determining eligibility and/or        communicating an insurance claim associated with provision of a        statin pharmaceutical composition, e.g., based on insurance        information stored in a respective user profile 234.

In some embodiments, the assessment module 252, the re-assessment module254, and/or the fulfillment module 228 is accessible within any browser(e.g., phone, tablet, laptop/desktop, or smartwatch). In someembodiments, the assessment module 252, re-assessment module 254, and/orfulfillment module 228 run on native device frameworks, and is availablefor download onto a user device 102 running an operating system 202 suchas Android, iOS, or WINDOWS.

In some embodiments, one or more of the above identified data elementsor modules (e.g., assessment module 252, fulfillment module 228-1, etc.)of the statin pharmaceutical composition OTC dispensing device 250 forqualifying a human subject for an over-the-counter provision of a statinpharmaceutical composition to lower cholesterol is stored in one or moreof the previously described memory devices, and correspond to a set ofinstructions for performing a function described above. Theabove-identified data, modules or programs (e.g., sets of instructions)need not be implemented as separate software programs, procedures ormodules, and thus various subsets of these modules may be combined orotherwise re-arranged in various embodiments. In some embodiments, thememory 192 and/or 290 optionally stores a subset of the modules and datastructures identified above. Furthermore, in some embodiments the memory192 and/or 290 stores additional modules and data structures notdescribed above.

In some embodiments, a statin pharmaceutical composition OTC dispensingdevice 250 for qualifying a human subject for an over-the-counterprovision of a statin pharmaceutical composition to lower cholesterol isa smart phone (e.g., an iPhone, Blackberry, etc.), a laptop, a tabletcomputer, a desktop computer, a smart watch, or another form ofelectronic device (e.g., a gaming console, a kiosk, a virtual realitysystem, etc.). In some embodiments, the statin pharmaceuticalcomposition OTC dispensing device 250 is not mobile. In someembodiments, the statin pharmaceutical composition OTC dispensing device250 is mobile.

In some embodiments, the statin pharmaceutical composition OTCdispensing device 250 is not a smart phone but rather is a tabletcomputer, desktop computer, emergency vehicle computer, or other form orwired or wireless networked device. In the interest of brevity andclarity, only a few of the possible components of the statinpharmaceutical composition OTC dispensing device 250 are shown in FIG. 2in order to better emphasize the additional software modules that areinstalled on the statin pharmaceutical composition OTC dispensing device250.

FIGS. 3A and 3B collectively provide a description of a user device 102that can be used with the present disclosure. The user device 102illustrated in FIGS. 3A and 3B has one or more processing units (CPU's)374, peripherals interface 370, memory controller 368, a network orother communications interface 384, a memory 392 (e.g., random accessmemory), a user interface 378, the user interface 378 including adisplay 382 and input 380 (e.g., a keyboard, a keypad, a touch screen),an optional accelerometer 317, an optional GPS 319, optional audiocircuitry 372, an optional speaker 360, an optional microphone 362, oneor more optional intensity sensors 364 for detecting intensity ofcontacts on the user device 102 (e.g., a touch-sensitive surface such asa touch-sensitive display system 382 of the user device 102), anoptional input/output (I/O) subsystem 366, one or more optional opticalsensors 373, one or more communication busses 313 for interconnectingthe aforementioned components, and a power supply 376 for powering theaforementioned components.

In some embodiments, the input 380 is a touch-sensitive display, such asa touch-sensitive surface. In some embodiments, the user interface 378includes one or more soft keyboard embodiments. The soft keyboardembodiments may include standard (e.g., QWERTY) and/or non-standardconfigurations of symbols on the displayed icons.

The user device 102 illustrated in FIGS. 3A and 3B optionally includes,in addition to accelerometer(s) 317, a magnetometer and a GPS 319 (orGLONASS or other global navigation system) receiver for obtaininginformation concerning a location and/or an orientation (e.g., portraitor landscape) of the user device 102 and/or for determining an amount ofphysical exertion by the subject.

It should be appreciated that the user device 102 illustrated in FIGS.3A and 3B is only one example of a multifunction device that may be usedfor performing a survey (e.g., assessment module 252) in order toqualify for an over-the-counter provision of a statin pharmaceuticalcomposition to lower cholesterol, and that the user device 102optionally has more or fewer components than shown, optionally combinestwo or more components, or optionally has a different configuration orarrangement of the components. The various components shown in FIGS. 3Aand 3B are implemented in hardware, software, firmware, or a combinationthereof, including one or more signal processing and/or applicationspecific integrated circuits.

Memory 392 of the user device 102 illustrated in FIGS. 3A and 3Boptionally includes high-speed random access memory and optionally alsoincludes non-volatile memory, such as one or more magnetic disk storagedevices, flash memory devices, or other non-volatile solid-state memorydevices. Access to memory 392 by other components of the statinpharmaceutical composition OTC dispensing device 250, such as CPU(s) 374is, optionally, controlled by the memory controller 368. In someembodiments, the memory 392 of the user device 102 illustrated in FIGS.3A and 3B optionally includes:

-   -   an operating system 302 that includes procedures for handling        various basic system services;    -   the assessment module 252 for qualifying a subject for an        initial over-the-counter provision of a statin pharmaceutical        composition, e.g., as described above in conjunction with the        statin pharmaceutical composition OTC dispensing device 250, the        assessment module including;        -   a first plurality of filters 214 (e.g., the first plurality            of assessment filters 214-1), e.g., as described above in            conjunction with the statin pharmaceutical composition OTC            dispensing device 250, e.g., including one or more of an age            filter 216-1, a pregnancy filter 216-2, a severe drug            interaction filter 216-3, a cardiac event filter 216-4, a            total cholesterol filter 216-5, a LDL cholesterol filter            216-6, a HDL cholesterol filter 216-7, a triglyceride filter            216-8, a blood pressure filter 216-9, an atherosclerotic            cardiovascular disease (ASCVD) risk pooled cohort equation            filter 216-10, and a liver condition filter 216-11;        -   the second plurality of filters 220 (e.g., the second            plurality of assessment filters 220-1) used in conjunction            with assessment module 252, e.g., as described above in            conjunction with the statin pharmaceutical composition OTC            dispensing device 250, e.g., including an alcohol            consumption filter 222-1, an adverse reaction filter 222-2,            and a moderate drug interaction filter 222-3;    -   a re-assessment module 254, e.g., as described above in        conjunction with the statin pharmaceutical composition OTC        dispensing device 250;    -   a re-assessment module 254 for re-qualifying a subject for an        over-the-counter provision of a statin pharmaceutical        composition to lower cholesterol, e.g., as described above in        conjunction with the statin pharmaceutical composition OTC        dispensing device 250, the re-assessment module including:        -   a first plurality of re-assessment filters 214-2, e.g., as            described above in conjunction with the statin            pharmaceutical composition OTC dispensing device 250,            including re-assessment filters 216 associated with            corresponding re-assessment survey questions 208 and one or            more triggering conditions 218;        -   a second plurality of re-assessment filters 220-2, e.g., as            described above in conjunction with the statin            pharmaceutical composition OTC dispensing device 250,            including re-assessment filters 222 associated with            corresponding re-assessment survey questions 212, triggering            conditions 224, and warnings 226.

In some embodiments, the optional accelerometer 317, optional GPS 319,and/or magnetometer of the user device 102 or such components are usedto recommend to qualifying subjects one or more suitable destinationsfor delivery of a provision of the statin pharmaceutical compositionover-the-counter. In some embodiments, the GPS 319 is used to determineif a subject is geographically restricted for an OTC provision of thestatin pharmaceutical composition. Geographical restrictions include butare not limited to a subject residing outside of delivery or shippingregions, marketing restrictions, and/or government regulations.

The peripherals interface 370 can be used to couple input and outputperipherals of the device to CPU(s) 374 and memory 392. The one or moreprocessors 374 run or execute various software programs and/or sets ofinstructions stored in memory 392, such as the survey module 204, toperform various functions for the user device 102 and to process data.

In some embodiments, the peripherals interface 370, CPU(s) 374, andmemory controller 368 are optionally implemented on a single chip. Insome other embodiments, they are implemented on separate chips.

RF (radio frequency) circuitry of network interface 384 receives andsends RF signals, also called electromagnetic signals. In someembodiments, the survey module 252/254, survey questions 208/212,answers to survey questions 208/212 (e.g., information sets), and/or theover-the-counter drug facts label 230 are communicated to the subjectdevice 102 using this RF circuitry. In some embodiments, the RFcircuitry 384 converts electrical signals to/from electromagneticsignals and communicates with communications networks and othercommunications devices and/or the data collection device 200 and/or thestatin pharmaceutical composition OTC dispensing device 250 via theelectromagnetic signals. The RF circuitry 384 optionally includeswell-known circuitry for performing these functions, including but notlimited to an antenna system, an RF transceiver, one or more amplifiers,a tuner, one or more oscillators, a digital signal processor, a CODECchipset, a subscriber identity module (SIM) card, memory, and so forth.RF circuitry 384 optionally communicates with the communication network106. In some embodiments, the circuitry 384 does not include RFcircuitry and, in fact, is connected to the network 106 through one ormore hard wires (e.g., an optical cable, a coaxial cable, or the like).

In some embodiments, the audio circuitry 372, the optional speaker 360,and the optional microphone 362 provide an audio interface between thesubject and the user device 102. The audio circuitry 372 receives audiodata from the peripherals interface 370, converts the audio data toelectrical signals, and transmits the electrical signals to the speaker360. The speaker 360 converts the electrical signals to human-audiblesound waves. In some embodiments, the speaker 360 converts theelectrical signals to human-inaudible sound waves. The audio circuitry372 also receives electrical signals converted by the microphone 362from sound waves. The audio circuitry 372 converts the electrical signalto audio data and transmits the audio data to peripherals interface 370for processing. Audio data is, optionally, retrieved from and/ortransmitted to the memory 392 and/or the RF circuitry 384 by theperipherals interface 370.

In some embodiments, the power supply 376 optionally includes a powermanagement system, one or more power sources (e.g., battery, alternatingcurrent (AC)), a recharging system, a power failure detection circuit, apower converter or inverter, a power status indicator (e.g., alight-emitting diode (LED)) and any other components associated with thegeneration, management and distribution of power in portable devices.

In some embodiments, the user device 102 optionally also includes one ormore optical sensors 373. The optical sensor(s) 373 optionally includecharge-coupled device (CCD) or complementary metal-oxide semiconductor(CMOS) phototransistors. The optical sensor(s) 373 receive light fromthe environment, projected through one or more lens, and converts thelight to data representing an image. The optical sensor(s) 373optionally capture still images and/or video. In some embodiments, anoptical sensor is located on the back of the user device 102, oppositethe display 382 on the front of the user device 102, so that the input380 is enabled for use as a viewfinder for still and/or video imageacquisition. In some embodiments, another optical sensor 373 is locatedon the front of the user device 102 so that an image of the subject isobtained (e.g., to verify the health, condition, or identity of thesubject as part of qualifying the subject for an over-the-counterprovision of a statin pharmaceutical composition to lower cholesterol),to help diagnose a subject's condition remotely, or to acquire visualphysiological measurements of the subject, etc.)

As illustrated in FIGS. 3A and 3B, the user device 102 preferablyincludes an operating system 302 that includes procedures for handlingvarious basic system services. The operating system 302 (e.g., iOS,DARWIN, RTXC, LINUX, UNIX, OS X, WINDOWS, or an embedded operatingsystem such as VxWorks) includes various software components and/ordrivers for controlling and managing general system tasks (e.g., memorymanagement, storage device control, power management, etc.) andfacilitates communication between various hardware and softwarecomponents.

In some embodiments, the user device 102 is a smart phone or a smartwatch. In other embodiments, the user device 102 is not a smart phone ora smart watch but rather is a tablet computer, a desktop computer, anemergency vehicle computer, or other form or wired or wireless networkeddevice. In the interest of brevity and clarity, only a few of thepossible components of the user device 102 are shown in FIGS. 3A and 3Bin order to better emphasize the additional software modules that areinstalled on the user device 102.

While the system 48 disclosed in FIG. 1 can work standalone, in someembodiments it can also be linked with an electronic medical recordssystem to exchange information in any way.

Now that details of a system 48 for qualifying a human subject for anover-the-counter provision of a statin pharmaceutical composition tolower cholesterol have been disclosed, details regarding methods (e.g.,an assessment method 4000 of FIG. 4 and/or a re-assessment method 5000of FIG. 5), including processes and features to be performed by thesystem, in accordance with an embodiment of the present disclosure, aredisclosed with reference to FIGS. 4 and 5, respectively. In someembodiments, such processes and features of the system 48 are carriedout by the assessment module 252, the re-assessment module 254, thefulfillment module 228-1, and/or the re-fulfillment module 228-2illustrated in FIGS. 2 and 3. In some embodiments, the assessment module252, the re-assessment module 254, the fulfillment module 228-1, and/orthe re-fulfillment module 228-1 are a single software module.

In some embodiments, e.g., as described with reference to FIGS. 4 and 8below, the disclosure provides a method for qualifying a subject for anover-the-counter provision of a statin pharmaceutical composition. Themethod includes obtaining an information set about the subject, e.g., bytransmitting survey questions to the subject and/or accessing a databaseentry relating to the subject (such as an electronic health recordand/or a private subject profile data store 232). In some embodiments,the information set includes a plurality of the example characteristicsprovided in Table 1. The method also includes applying some or all ofthe information set to a qualification algorithm that includes at leastone filter of a first type and one filter of a second type. Filters ofthe first type interrogate information from the information set and whenbaseline qualification conditions are not met, the filter fires,preventing the subject from becoming qualified to receive a provision ofthe statin pharmaceutical composition. In some embodiments, a pluralityof filters of the first type are applied. In some embodiments, theplurality of filters of the first type include a plurality of theexample assessment filters provided in Table 2. Filters of the secondtype interrogate information from the information set and when baselinequalification conditions are not met, the filter fires, providing awarning to the subject of a risk factor associated with taking thestatin pharmaceutical composition. However, upon confirmation of thewarning from the subject, the filter does not prevent the subject frombeing qualified to receive a provision of the stain pharmaceuticalcomposition. In some embodiments, a plurality of filters of the secondtype are applied. In some embodiments, the plurality of filters of thesecond type include a plurality of the example assessment filtersprovided in Table 4.

In some embodiments, the method further includes obtainingacknowledgment from the subject for each warning issued to the subjectby any filter in the second plurality of assessment filters, e.g.,confirming that the subject has discussed the risk factor associatedwith each warning issued to the subject by any filter in the secondplurality of assessment filters with a physician. In some embodiments,the method then includes proceeding with a fulfillment process when (a)no filter in the first plurality of assessment filters has been firedand (b) the subject has acknowledged each warning associated with eachfilter in the second plurality of assessment filters that was fired. Insome embodiments, the fulfillment process includes storing an indicationin a subject profile of an initial order for the statin pharmaceuticalcomposition, communicating an over the counter drug facts label for thestatin pharmaceutical composition to the subject, and authorizing, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, provision of the statin pharmaceuticalcomposition to the subject. In some embodiments, the method alsoincludes administering (which will typically be performed by the subjectthemselves), after authorization of the provision, the statinpharmaceutical composition to the subject.

In some embodiments, e.g., as described with reference to FIGS. 5 and 9below, the disclosure provides a method for re-qualifying a subject foran over-the-counter provision of a statin pharmaceutical composition.The method includes obtaining an information set about the subject,e.g., by transmitting survey questions to the subject and/or accessing adatabase entry relating to the subject (such as an electronic healthrecord and/or a private subject profile data store 232). In someembodiments, the information set includes a plurality of the examplecharacteristics provided in Table 5. The method also includes applyingsome or all of the information set to a qualification algorithm thatincludes at least one filter of a first type and one filter of a secondtype. Filters of the first type interrogate information from theinformation set and when baseline qualification conditions are not met,the filter fires, preventing the subject from becoming re-qualified toreceive a provision of the statin pharmaceutical composition. In someembodiments, a plurality of filters of the first type are applied. Insome embodiments, the plurality of filters of the first type include aplurality of the example assessment filters provided in Table 6. Filtersof the second type interrogate information from the information set andwhen baseline qualification conditions are not met, the filter fires,providing a warning to the subject of a risk factor associated withtaking the statin pharmaceutical composition. However, upon confirmationof the warning from the subject, the filter does not prevent the subjectfrom being qualified to receive a provision of the stain pharmaceuticalcomposition. In some embodiments, a plurality of filters of the secondtype are applied. In some embodiments, the plurality of filters of thesecond type include a plurality of the example assessment filtersprovided in Table 7.

In some embodiments, the method further includes obtainingacknowledgment from the subject for each warning issued to the subjectby any filter in the second plurality of assessment filters, e.g.,confirming that the subject has discussed the risk factor associatedwith each warning issued to the subject by any filter in the secondplurality of assessment filters with a physician. In some embodiments,the method then includes proceeding with a fulfillment process when (a)no filter in the first plurality of assessment filters has been firedand (b) the subject has acknowledged each warning associated with eachfilter in the second plurality of assessment filters that was fired. Insome embodiments, the fulfillment process includes storing an indicationin a subject profile of a re-order for the statin pharmaceuticalcomposition, communicating an over the counter drug facts label for thestatin pharmaceutical composition to the subject, and authorizing, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, provision of the statin pharmaceuticalcomposition to the subject. In some embodiments, the method alsoincludes administering (which will typically be performed by the subjectthemselves), after authorization of the provision, the statinpharmaceutical composition to the subject.

FIG. 4 illustrates method 4000 for qualifying (4002) a human subject foran over-the-counter provision of a statin pharmaceutical composition forlowering cholesterol, e.g., thereby, treating and/or preventing heartdisease, using a computer system such as a statin pharmaceuticalcomposition OTC dispensing device 250. As illustrated in FIG. 2, thestatin pharmaceutical composition OTC dispensing device (e.g., device250) includes one or more processors (e.g., processor 274) and a memory(e.g., memory 192 and/or 290). The memory stores non-transitoryinstructions that, when executed by the one or more processors, performa method.

As used herein, the term “statin” refers to a class of drugs commonlyreferred to as HMG CoA reductase inhibitors. The statins are used toreduce blood cholesterol levels in patients in need of such treatment.The site of action of the statins is in the liver. Examples of statinsinclude, but are not limited, to atorvastatin (LIPITOR®), cerivastastin,fluvastatin (LESCOL®, LESCOL XL®), lovastatin (ALTOPREV®), pitavastatin(LIVALO®), pravastatin (PRAVACHO®), simvastatin, rosuvastatin(CRESTOR®), and simvastatin (ZOCOR®). Example chemical structures ofstatins are disclosed in FIG. 10.

Method 4000 involves collecting relevant biographical and medicalinformation about the subject, applying the collected information to analgorithm that applies the information against one or more filters of afirst type and one or more filters of a second type, and providingaccess to a statin pharmaceutical composition when each of the filtersis satisfied. The one or more filters of the first type terminate theprocess without qualifying the patient for access to an over-the-counterstatin pharmaceutical agent when fired. The one or more filters of thesecond type trigger transmission of a warning to the subject when fired.The subject must confirm any transmitted warnings, which optionallyinclude confirmation that certain conditions precedent have been met(such as having a discussion with a medical professional and receivingadvice that the statin pharmaceutical composition is safe to take),before the subject is qualified to receive a provision of the statinpharmaceutical agent.

Referring to blocks 4004 and 4006 of FIG. 4A, in some embodiments thestatin pharmaceutical composition includes rosuvastatin (CRESTOR®) as anactive ingredient. In some embodiments, the statin pharmaceuticalcomposition includes a composition disclosed in U.S. Pat. Nos. 6,316,460or 6,858,618, each of which is hereby incorporated by reference, as anactive ingredient.

In some embodiments, the statin pharmaceutical composition includesatorvastatin (LIPITOR®) as an active ingredient.

In some embodiments, the statin pharmaceutical composition includesfluvastatin (LESCOL®, LESCOL XL®) as an active ingredient. In someembodiments, the statin pharmaceutical composition includes acomposition disclosed in U.S. Pat. No. 6,242,003, which is herebyincorporated by reference, as an active ingredient.

In some embodiments, the statin pharmaceutical composition includeslovastatin (ALTOPREV®) as an active ingredient.

In some embodiments, the statin pharmaceutical composition includespitavastatin (LIVALO®) as an active ingredient. In some embodiments, thestatin pharmaceutical composition includes a composition disclosed inU.S. Pat. Nos. 5,856,336, 7,022,713, or 8,557,993, each of which ishereby incorporated by reference, as an active ingredient.

In some embodiments, the statin pharmaceutical composition includespravastatin (PRAVACHOL®) as an active ingredient.

In some embodiments, the statin pharmaceutical composition includessimvastatin (ZOCOR®) as an active ingredient.

In some embodiments, the statin pharmaceutical composition includes astatin composition described in Lee et al., 2007, “Comparison ofEfficacy and Tolerability of Pitavastatin and Atorvastatin: an 8-Week,Multicenter, Randomized, Open-Label, Dose-Titration Study in KoreanPatients with Hypercholesterolemia,” Clin Ther. 2007; 29:2365-73;Bradford et al., 1990, “Expanded clinical evaluation of lovastatin(EXCEL) study design and patient characteristics of a double blind,placebo controlled study in patients with moderatehypercholesterolemia.American Journal of Cardiology 66: p. 44B-55B;Serruys et al., 2002, “Fluvastatin for Prevention of Cardiac EventsFollowing Successful First Percutaneous Coronary Intervention: ARandomized Controlled Trial.,” JAMA 287:p. 3215-3222; Sacks et al. 1996,“The effect of pravastatin on coronary events after myocardialinfarction in patients with average cholesterol levels. Cholesterol andRecurrent Events Trial investigators,” New England Journal of Medicine,1996. 335(14): p. 001-9; Anonymous, 2002 “Heart Protection StudyCollaborative Group, MRC/BHF Heart Protection Study of cholesterollowering with simvastatin in 20,536 high-risk individuals: a randomisedplacebo-controlled trial,” Lancet 360: p. 7-22; Jones et al., 2003,“Comparison of the efficacy and safety of rosuvastatin versusatorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial),” Am J Cardiol. 92 (2): 152-60 each of which is hereby incorporated byreference.

In some embodiments, the statin pharmaceutical composition comprises astatin and another lipid-lowering drug, such as Atorvastatin/Ezetimibe(LIPTRUZET®), Lovastatin+Niacin (ADVICOR®), Simvastatin/Ezetimibe(VYTORIN®), or Simvastatin/Niacin-ER (SIMCOR®).

In some embodiments, the statin pharmaceutical composition is a prodrug.As used herein, a prodrug refers to a pharmaceutical composition thatincludes a biologically inactive compound that is metabolized in vivo togenerate the active form of the drug. For instance, in some embodimentsthe prodrug statin pharmaceutical composition includes atorvastatin,fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, orsimvastatin.

In some embodiments, the statin pharmaceutical composition includesrosuvastatin (e.g., CRESTOR®) as an active ingredient, and the subjectis authorized for a daily dosage of from about 2.5 mg to about 20 mg. Insome embodiments, the subject is authorized for a daily dosage of from2.5 mg to 15 mg rosuvastatin. In some embodiments, the subject isauthorized for a daily dosage of from 5 mg to 15 mg rosuvastatin. Insome embodiments, the subject is authorized for a daily dosage of from 5mg to 10 mg rosuvastatin. In some embodiments, the subject is authorizedfor a daily dosage of 5 mg rosuvastatin. In some embodiments, thesubject is authorized for a daily dosage of 10 mg rosuvastatin. In otherembodiments, the subject is authorized for a daily dosage of 2.5 mg, 7.5mg, 12.5 mg, 15 mg, 17.5 mg, or 20 mg rosuvastatin.

In some embodiments, the statin pharmaceutical composition includes acomposition disclosed in U.S. Pat. Nos. 6,316,460 or 6,858,618, each ofwhich is hereby incorporated by reference, as an active ingredient andthe subject is authorized for a daily dosage of from about 2.5 mg toabout 20 mg, a daily dosage of from 2.5 mg to 15 mg, a daily dosage offrom 5 mg to 15 mg, a daily dosage of from 5 mg to 10 mg, a daily dosageof 5 mg, a daily dosage of 10 mg, or a daily dosage of 2.5 mg, 7.5 mg,12.5 mg, 15 mg, 17.5 mg, or 20 mg of the active composition disclosed inU.S. Pat. Nos. 6,316,460 or 6,858,618.

In some embodiments, the statin pharmaceutical composition includesfluvastatin (e.g., LESCOL®) as an active ingredient, and the subject isauthorized for a daily dosage of from about 5 mg to about 60 mg. In someembodiments, the subject is authorized for a daily dosage of from 5 mgto 40 mg fluvastatin. In some embodiments, the subject is authorized fora daily dosage of from 10 mg to 40 mg fluvastatin. In some embodiments,the subject is authorized for a daily dosage of from 20 mg to 40 mgfluvastatin. In some embodiments, the subject is authorized for a dailydosage of 20 mg fluvastatin. In some embodiments, the subject isauthorized for a daily dosage of 40 mg fluvastatin. In otherembodiments, the subject is authorized for a daily dosage of 5 mg, 10mg, 30 mg, 50 mg, or 60 mg fluvastatin.

In some embodiments, the statin pharmaceutical composition includes anactive composition disclosed in U.S. Pat. No. 6,242,003, which is herebyincorporated by reference, and the subject is authorized for a dailydosage of from about 5 mg to about 60 mg, a daily dosage of from 5 mg to40 mg, a daily dosage of from 10 mg to 40 mg, a daily dosage of from 20mg to 40 mg, a daily dosage of 20 mg, a daily dosage of 40 mg, or adaily dosage of 5 mg, 10 mg, 30 mg, 50 mg, or 60 mg of the activecomposition disclosed in U.S. Pat. No. 6,242,003.

In some embodiments, the statin pharmaceutical composition includesatorvastatin (e.g., LIPITOR®) as an active ingredient, and the subjectis authorized for a daily dosage of from about 5 mg to about 60 mg. Insome embodiments, the subject is authorized for a daily dosage of from 5mg to 40 mg atorvastatin. In some embodiments, the subject is authorizedfor a daily dosage of from 10 mg to 40 mg atorvastatin. In someembodiments, the subject is authorized for a daily dosage of from 20 mgto 40 mg atorvastatin. In some embodiments, the subject is authorizedfor a daily dosage of 10 mg atorvastatin. In some embodiments, thesubject is authorized for a daily dosage of 20 mg atorvastatin. In someembodiments, the subject is authorized for a daily dosage of 40 mgatorvastatin. In other embodiments, the subject is authorized for adaily dosage of 5 mg, 10 mg, 30 mg, 50 mg, or 60 mg atorvastatin.

In some embodiments, the statin pharmaceutical composition includespitavastatin (e.g., LIVALO®) as an active ingredient, and the subject isauthorized for a daily dosage of from about 0.5 mg to about 4 mg. Insome embodiments, the subject is authorized for a daily dosage of from 1mg to 4 mg pitavastatin. In some embodiments, the subject is authorizedfor a daily dosage of from 1 mg to 2 mg pitavastatin. In someembodiments, the subject is authorized for a daily dosage of 1 mgpitavastatin. In some embodiments, the subject is authorized for a dailydosage of 2 mg pitavastatin. In other embodiments, the subject isauthorized for a daily dosage of 0.5 mg, 3 mg, or 40 mg pitavastatin.

In some embodiments, the statin pharmaceutical composition includeslovastatin (e.g., MEVACOR®) as an active ingredient, and the subject isauthorized for a daily dosage of from about 5 mg to about 60 mg. In someembodiments, the subject is authorized for a daily dosage of from 5 mgto 40 mg lovastatin. In some embodiments, the subject is authorized fora daily dosage of from 10 mg to 40 mg lovastatin. In some embodiments,the subject is authorized for a daily dosage of from 20 mg to 40 mglovastatin. In some embodiments, the subject is authorized for a dailydosage of 10 mg lovastatin. In some embodiments, the subject isauthorized for a daily dosage of 20 mg lovastatin. In some embodiments,the subject is authorized for a daily dosage of 40 mg lovastatin. Inother embodiments, the subject is authorized for a daily dosage of 5 mg,10 mg, 30 mg, 50 mg, or 60 mg lovastatin.

In some embodiments, the statin pharmaceutical composition includespravastatin (e.g., PRAVACHOL®) as an active ingredient, and the subjectis authorized for a daily dosage of from about 5 mg to about 60 mg. Insome embodiments, the subject is authorized for a daily dosage of from 5mg to 40 mg pravastatin. In some embodiments, the subject is authorizedfor a daily dosage of from 10 mg to 40 mg pravastatin. In someembodiments, the subject is authorized for a daily dosage of from 20 mgto 40 mg pravastatin. In some embodiments, the subject is authorized fora daily dosage of 10 mg pravastatin. In some embodiments, the subject isauthorized for a daily dosage of 20 mg pravastatin. In some embodiments,the subject is authorized for a daily dosage of 40 mg pravastatin. Inother embodiments, the subject is authorized for a daily dosage of 5 mg,10 mg, 30 mg, 50 mg, or 60 mg pravastatin.

In some embodiments, the statin pharmaceutical composition includessimvastatin (e.g., ZOCOR®) as an active ingredient, and the subject isauthorized for a daily dosage of from about 2.5 mg to about 40 mg. Insome embodiments, the subject is authorized for a daily dosage of from 5mg to 40 mg simvastatin. In some embodiments, the subject is authorizedfor a daily dosage of from 5 mg to 20 mg simvastatin. In someembodiments, the subject is authorized for a daily dosage of from 5 mgto 10 mg simvastatin. In some embodiments, the subject is authorized fora daily dosage of 5 mg simvastatin. In some embodiments, the subject isauthorized for a daily dosage of 10 mg simvastatin. In some embodiments,the subject is authorized for a daily dosage of 20 mg simvastatin. Inother embodiments, the subject is authorized for a daily dosage of 2.5mg, 30 mg or 40 mg simvastatin.

In some embodiments, the lowering of cholesterol is to treat and/orprevent heart disease. Typically, this treatment and/or prevention ofheart disease is accomplished by inhibiting HMG-CoA reductase in theliver.

As described in detail below, method 4000 includes eliciting medicalinformation about the user (e.g., information sets), which is used toqualify or disqualify the subject for an over-the-counter provision ofthe statin pharmaceutical composition. However, in some embodiments,before beginning to elicit this information, the system registers thesubject and/or ensures that the subject is prepared to proceed throughthe qualification process. For example, in some embodiments, the systemfirst determines whether the subject has already registered, waspreviously qualified, and/or previously received a provision of theover-the-counter provision of the statin pharmaceutical composition.This determination may occur by comparing the first information setand/or additional information provided by the subject with data of asubject profile data store (e.g., subject profile store 323 of FIG. 2).

When the subject has not yet registered with the system, device 250registers the subject as a new user and creates a corresponding userprofile (e.g., regardless of whether the subject previously received aprescription provision of the statin pharmaceutical composition). Thesystem then performs an assessment method (e.g., assessment method 4000)to qualify the subject for a first over-the-counter provision of thestatin pharmaceutical composition.

When the subject already has a user profile 234, e.g., as verified witha user password, the device registers the user as a returning customer.When the returning subject has previously received an over-the-counterprovision of the statin pharmaceutical composition, the system performsa re-assessment method (e.g., re-assessment method 5000) to qualify thesubject for a subsequent provision. When the returning subject has notpreviously received an over-the-counter provision of the statinpharmaceutical composition (e.g., because they did not previouslyqualify or choose not to purchase the composition after beingqualified), the system performs an assessment method (e.g., assessmentmethod 4000) to qualify the patient for a first over-the-counterprovision of the statin pharmaceutical composition.

In some embodiments, when a new user does not already have a userprofile 234 (e.g., the subject has not previously been qualified for anover-the-counter provision of the statin pharmaceutical composition) thedevice registers the user as a new user and creates a corresponding userprofile, regardless of whether the subject previously received aprescription provision of the statin pharmaceutical composition. In someembodiments, when a new user has not previously been qualified for anover-the-counter provision of the statin pharmaceutical composition, buthas received a prescription for the statin pharmaceutical composition,the device will consider the new user a returning user and will performa re-order qualification (e.g., via method 5000), rather than an initialqualification (e.g., via method 4000).

In some embodiments, prior to eliciting medical information (e.g., someor all of the first information set) from the subject, the systemprompts (e.g., 802 of FIG. 8A) to confirm that they have adequateprivacy to provide sensitive medical information and/or that they are inpossession of the medical information required to complete thequalification process. For example, in some embodiments the systemprompts (e.g., 804 of FIG. 8A) the user to confirm that they haveknowledge of their blood pressure, cardiovascular history, etc.

Blocks 4008 and 4010. Referring to block 4008 of FIG. 4A, the methodincludes providing an assessment survey that obtains an information setfrom the subject. By way of the assessment survey, a plurality ofassessment survey results to survey questions 208, 212 (e.g., one ormore of the survey questions set forth in Table 1) are obtained (e.g.,the device 250 transmits one or more assessment survey questions to theuser, prompting a response, and then receives a response to the one ormore assessment survey questions back from the subject). In someembodiments, the information set include some or all of thecharacteristics listed in Table 1. For example, in some embodiments, theinformation set includes 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,16, 17, or all 18 of the characteristics listed in Table 1. In oneembodiment, the plurality of assessment survey results includes at leastcharacteristics 1-8 as provided in Table 1. In one embodiment, theplurality of assessment survey results includes at least characteristics1-15 as provided in Table 1.

It will be appreciated that the survey questions 208, 212 and filters216, 222 (e.g., first plurality of assessment filters 216-1 and secondplurality of assessment filters 222-1) applied to the information setthereof may vary depending upon the statin pharmaceutical compositionbeing distributed. This varying is due to differences in thecontraindication profiles of the various the statin pharmaceuticalcompositions, e.g., due to different drug-drug interactions, routes ofdrug clearance, etc. of the different the statin pharmaceuticalcompositions. For example, co-administration of warfarin with a singleoral dose of atorvastatin had no significant effect on thepharmacokinetics of atorvastatin. As such, in some embodiments, anassessment survey, or similarly a re-assessment survey, qualifying asubject for an OTC provision of simvastatin may ask whether the subjectconsumes warfarin, while a similar survey qualifying a subject for OTCuse of rosuvastatin may not.

Referring to block 4010, and as further informed by the example workflowillustrated in FIG. 8, in some embodiments the first information setincludes a sex of the subject (e.g., responsive to a survey question 208that is associated with a decision point (806)), an age of the subject(e.g., responsive to a survey question 208 that is associated with(808-1 or 808-2) an age filter 216-1), when the subject isfemale—whether the subject is one of pregnant or breastfeeding (e.g.,responsive to a survey question 208 that is associated with (810) apregnancy filter 216-2), whether the subject is taking one or morecompositions that interact with the statin pharmaceutical composition(e.g., responsive to a survey question 208 that is associated with (814)a severe drug interaction filter 216-3), whether the subject has everhad a cardiac event (e.g., responsive to a survey question 208 that isassociated with (816 and/or 818) a cardiac event filter 216-4), a totalcholesterol level of the subject (e.g., responsive to a survey question208 that is associated with (824) a total cholesterol filter 216-5), alow-density lipoprotein (LDL) cholesterol level of the subject (e.g.,responsive to a survey question 208 that is associated with (826) an LDLcholesterol filter 216-6), a high-density lipoprotein (HDL) cholesterollevel of the subject (e.g., responsive to a survey question 208 that isassociated with (828) an HDL cholesterol filter 216-7), a triglyceridelevel of the subject (e.g., responsive to a survey question 208 that isassociated with (830) a triglyceride filter 216-8), a systolic bloodpressure of the subject (e.g., responsive to a survey question 208 thatis associated with (832) a blood pressure filter 216-9), a diastolicblood pressure of the subject (e.g., responsive to a survey question 208that is associated with (834) a blood pressure filter 216-9), whetherthe subject has a liver condition (e.g., responsive to a survey question208 that is associated with (852) a blood pressure filter 216-11), analcohol consumption status of the subject (e.g., responsive to a surveyquestion 212 that is associated with (856) an alcohol consumption filter222-1), and whether the subject has had an adverse reaction to acholesterol lowering composition (e.g., responsive to a survey question212 that is associated with (858) an adverse reaction filter 222-1).

In some embodiments, the assessment survey includes questions thatelicit responses providing some or all of the characteristics listed inTable 1. In some embodiments, the assessment survey includes questionscorresponding to the information set required for the methods describedherein. In other embodiments, the assessment survey includes questionscorresponding to only a subset of the information set required for themethods described herein. In such embodiments, one or more portions ofthe information set required for the methods described herein areacquired through other means (e.g., upon registration/subscription for aservice associated with qualifying the subject for over-the-countermedication, from a healthcare provider, from a prior survey, from adatabase associated with a pharmacy, from an electronic health recordassociated with the subject, from the subject profile data store 232,etc.) For example, in some embodiments, the subject provides a personalmedical identification associated with an insurer, a hospital, or otherhealthcare provider and information about the subject required for themethods described herein, e.g., one or more survey results, is acquiredfrom a preexisting database associated with the personal medicalidentification (e.g., a blood pressure measurement determined for thesubject).

TABLE 1 Example Medical Information Elicited from Assessment SurveyQuestions Result Example Characteristics 1 a sex of the subject 2 an ageof the subject 3 when the subject is female-whether the subject ispregnant or breastfeeding, 4 whether the subject is taking one or morecompositions that interact with the statin pharmaceutical composition 5whether the subject has ever had a cardiac event 6 a total cholesterollevel of the subject 7 a LDL cholesterol level of the subject 8 a HDLcholesterol level of the subject 9 a triglyceride level of the subject10 a systolic blood pressure of the subject 11 a diastolic bloodpressure of the subject 12 whether the subject has a lever condition 13an alcohol consumption status of the subject 14 whether the subject hashad an adverse reaction to a cholesterol lowering composition 15 a raceof the subject 16 whether the subject is taking a high blood pressuretreatment 17 a diabetes status of the subject 18 a smoking status of thesubject

It is contemplated that, in some embodiments, any one or more ofcharacteristics listed in Table 1 will not be elicited by the assessmentsurvey (e.g., will not be used for the assessment and/or will beobtained by other means). For example, in some embodiments, acharacteristic associated with a particular survey question will beinformative when qualifying a subject for one particular statin but notfor another statin. For instance, in some embodiments, an assessmentsurvey question is queried for lovastatin qualifying surveys but not forsimvastatin qualifying surveys (e.g., the assessment survey question isnot relevant for simvastatin). The skilled artisan will recognize thatdifferent statins carry different risk and drug interaction profiles.Accordingly, assessment survey information set (e.g., first informationset) required for qualifying a subject for access to one statin with aknown adverse drug interaction may not be necessary for qualifying thesame subject for access to a second statin.

Accordingly, it is contemplated that the characteristics elicited by theassessment survey questions 208 include any subset of survey resultsprovided in Table 1. For brevity, all possible combinations of thecharacteristics elicited by the assessment survey provided in Table 1are not specifically delineated here. However, the skilled artisan willeasily be able to envision any particular subset of the characteristicslisted in Table 1. Likewise, the skilled artisan may know of othercharacteristics, not listed in Table 1, that may be combined with anysubset of the characteristics listed in Table 1 to form the informationelicited by the assessment survey questions used in the methodsdescribed herein.

In some embodiments, the assessment survey and/or the re-assessmentsurvey is conducted by transmitting a plurality of respective questionsto the subject, e.g., some or all of the respective survey questions,and receiving answers to the plurality of respective survey questionsbefore applying any of the answers to respective filters. For example,with reference to the workflow in FIG. 8, in some embodiments, thedevice transmits questions relating to all of the assessment filters ofthe first plurality of assessment filters, all of the assessment filtersof the second plurality of assessment filters, or all of the assessmentfilters in the workflow (e.g., as a virtual assessment survey where allof the questions are displayed in a single user interface, or as aseries of questions displayed in consecutive user interfaces). Afterreceiving answers to all of the assessment survey questions, the devicethen applies an algorithm to run assessment information set against theassessment filters (e.g., sequentially or concurrently) to determinewhether the subject is qualified to receive a provision of the statinpharmaceutical composition. In alternative embodiments, the devicetransmits questions relating to relating to a subset of assessmentfilters of the first category class, e.g., for which it could not obtainanswers to the questions from an electronic database associated with thesubject such as electronic health record of the subject, and/or relatingto a subset of assessment filters of the second category class, e.g.,that it could not obtain answers to the questions from an electronicdatabase associated with the subject (e.g., as a virtual assessmentsurvey where such unanswered questions are displayed in a single userinterface, or as a series of questions displayed in consecutive userinterfaces). After receiving answers to all of the survey questions, thedevice then applies the answers to all of the filters (e.g.,sequentially or concurrently) to determine whether the subject isqualified to receive provision of the statin pharmaceutical composition.

In some embodiments, the assessment survey and/or the re-assessmentsurvey is conducted in a serial fashion, e.g., by transmitting a firstquestion or a first group of survey questions (e.g., associated with asingle respective filter) to the subject, receiving an answer to thesingle survey question or small group of survey questions, and applyingan algorithm by running the answer or answers through a filter, prior totransmitting a second question or second group of questions to thesubject. For example, with reference to the workflow in FIG. 8, in someembodiments the device transmits a first assessment question to thesubject, relating to the cardiac event history of the subject (e.g.,question 650 ‘Have you ever had any of the following: A heart attack,stroke, or an operation or procedure on your heart? Developed peripheralartery disease (PAD)?’ in FIG. 6C). After receiving the answer to thesurvey question (e.g., ‘yes or no’), the device applies the algorithm tothe answer by running the answer through a cardiac event filter (816).If the cardiac event filter is fired (e.g., in response to a “yes”answer), the device terminates (805) the process, and optionallyprovides the user with a message relating to why they are being denied aprovision of the statin pharmaceutical composition, a suggestion forfollowing-up with a medical professional (e.g., as illustrated in FIG.6B, when the survey answers indicate that the subject has had a historyof cardiac events (816), the device optionally terminates the process(805) and advises that the subject seek guidance from a professionalmedical practitioner), and/or a suggestion to make a lifestyle change(e.g., when the survey answers indicate that the subject has slightlyelevated blood pressure (832 and/or 834), the device terminates theprocess (803) and advises that the subject improve their diet orexercise routine which is consistent with current blood pressuretreatment guidelines), to treat or manage their blood pressure. In otherembodiments, the assessment survey and/or the reassessment survey iscompleted prior to applying any of the answers to the correspondingalgorithm.

In some embodiments, one or more survey questions are not transmitted toa respective subject in accordance with a result to a previous surveyquestion. For instance, in some embodiments where the ASCVD riskcalculation is bypassed by an indication that the subject has a historyof ASCVD (e.g., bypass mechanism 8443 in FIG. 8E), if an assessmentsurvey result indicates that a subject has a history of ASCVD (e.g., atstep 816 and/or 818 in FIG. 8B), one or more assessment survey questionsrelated to an ASCVD pooled cohort equation filter are bypassed (e.g.,not transmitted to the user) because the ASCVD pooled cohort filter canbe bypassed.

As described in detail below, the methods disclosed herein include stepsof applying information collected about a subject to a plurality offilters designed to identify contraindications—which render the subjectunsuitable for treatment with the statin pharmaceutical compositiongenerally or at least in the self-care environment (i.e., withoutphysician supervision)—and risk factors—which render administration ofthe statin pharmaceutical composition unnecessarily risky withoutfurther physician consultation. The contraindication and risk factorsdescribed herein are non-exhaustive, as the skilled artisan will know ofother possible contraindications or risk factors for a particular statinpharmaceutical composition. Moreover, as medical research progresses,new contraindications or risk factors may be discovered. Or, similarly,the classification of existing contraindications or risk factors maychange with additional medical research or consideration. For example, afactor considered to be a contraindication may be reclassified as a riskfactor, over time, or vice-a-versa.

Further, a contraindication for one statin pharmaceutical compositionmay only be a risk factor, or neither, for a different statinpharmaceutical composition, for example, based on different mechanisms,interaction, pharmacokinetic, and/or pharmacodynamics properties of therespective active ingredients. Similarly, a factor that is acontraindication or risk factor for a particular statin pharmaceuticalcomposition when administered at one dose, e.g., a high, moderate, orlow dose, may be classified differently when administered at a differentdose. For example, a contraindication for a statin pharmaceuticalcomposition administered at a high dose may only be a risk factor, orneither, when administered at a low dose. This is particularly true whenthe risk factor, e.g., a drug interaction, changes the bioavailabilityof the active ingredient by a certain factor, such that thebioavailability following high dose administration, but not low doseadministration, would increase beyond a safe threshold.

Blocks 4012-4132. Referring to block 4012 of FIG. 4B, the methodincludes applying an algorithm to the information set obtained through,at least in part, the assessment survey. Referring to block 4014, all ora portion of the information set is run against a first plurality ofassessment filters 214-1. As previously described, the first pluralityof assessment filters 214-1 includes a subset of filters 216. When arespective filter in the first plurality of assessment filters 214-1 isfired (e.g., in accordance with a determination that a portion of theinformation set indicates that a triggering condition 218 has been met),the subject is deemed not qualified for provision of the statinpharmaceutical composition and the method is terminated withoutprovision of the statin pharmaceutical composition.

For example, in some embodiments, the device transmits a prompt toprovide information about a possible contraindication for statin use(e.g., prompt 650 “Have you ever had a heart attack, stroke, or anoperation on your heart?,” as illustrated in FIG. 6A), receives aresponse to the prompt, and then applies an algorithm to the responseprovided by the subject (e.g., through a pregnancy filter as describedbelow). When the response indicates that a triggering condition has beenmet (e.g., the subject is pregnant), the filter is fired and the methodis terminated without authorizing provision of the statin pharmaceuticalcomposition to the subject. In some embodiments, the device transmits amessage explaining why authorization of the statin pharmaceuticalcomposition was denied. In some embodiments, the device transmits amessage suggesting the subject consult with a medical professional,e.g., when the subject is deemed to need a stronger dosage of the statinpharmaceutical composition than available via the system and/or when thesubject is deemed to be experiencing a medical emergency. For example,FIG. 6B illustrates an example message 652 provided to a subject whoclinked “Yes” in response to prompt 650, informing them that users witha history of cardiac events can have adverse effects to statin therapy,and advising them to consult with a clinician to discuss whether statintherapy would benefit them.

In some embodiments, e.g., when the method is terminated withoutprovision of the statin pharmaceutical composition, e.g., after a filterof the first type, the subject is prevented from attempting tore-qualify for the statin pharmaceutical composition for a predeterminedperiod of time (e.g., 30 days, 60 days, 90 days, one year, two years,etc.). This prevents the subject from abusing the systems and methods ofthe present disclosure.

Referring to blocks 4016-4132 of FIGS. 4B-4J, example assessment filters216 in the first plurality of assessment filters 214 and exampletriggering conditions 218 that cause the corresponding assessmentfilters to fire are described below.

TABLE 2 Example Assessment Filters of the First Plurality of AssessmentFilters Filter Type  1a an age filter  2a a pregnancy filter  3a asevere drug interaction filter  4a a cardiac event filter  5a a totalcholesterol filter  6a a LDL cholesterol filter  7a a HDL cholesterolfilter  8a a triglyceride filter  9a a blood pressure filter 10a anASCVD risk pooled cohort equation filter 11a a liver condition filter12a a risk enhancing factor filter

In some embodiments, the first plurality of assessment filters 214includes some or all of the filters 216 listed in Table 2. For example,in some embodiments, the first plurality of assessment filters 214-1includes 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or all 12 of the filters listedin Table 2. In one embodiment, the first plurality of assessment filtersincludes at least filters 1 a-11 a as provided in Table 2. In someembodiments, where the information set indicates one or more particularrisk enhancing factors, the first plurality of assessment filtersfurther includes a risk enhancing factor filter 12 a.

Accordingly, it is contemplated that in some embodiments the firstplurality of assessment filters includes any sub-set of filters 216provided in Table 2. Likewise, in some embodiments the skilled artisanmay know of other filters 216, not provided in Table 2, which may becombined with any subset of the filters 216 provided in Table 2 to formthe first plurality of assessment filters and corresponding informationset used in the methods described herein. For brevity, all possiblecombinations of the assessment filters 216 provided in Table 2 are notspecifically delineated here.

It is contemplated that, in some embodiments, any one or more of theassessment filters 216 provided in Table 2 will not be included in thefirst plurality of assessment filters. For example, in some embodiments,a characteristic associated with a particular survey result will beinformative if qualifying a subject for one particular statinpharmaceutical composition but not for another statin pharmaceuticalcomposition. In some embodiments, one or more of the filters 216provided in Table 2 is implemented as a second type filter (e.g.,included in a second plurality of assessment filters), as describedbelow, which generates a warning to the user and/or requires the userconfirm they have discussed an underlying risk triggering the filterwith a medical professional, e.g., instead of automatically terminatingthe process without authorizing provision of the statin pharmaceuticalcomposition. For example, in some cases, the decision to implement oneof the filters listed in Table 2 as a second type filter will be basedon a consideration specific to a particular statin compound and/ordosage of the statin compound. Similarly, in other cases, the decisionto implement one of the filters listed in Table 2 as a second typefilter will be based on a change in health and/or regulatory guidelines.

In some embodiments, the device is configured to conditionally bypassone or more of the filters 216 in the first plurality of assessmentfilters 214. For example, as illustrated in example implementation 800,when the device determines the subject is a male (e.g., as illustratedin step 806 in FIG. 8A) the pregnancy filter applied at step 810 isbypassed because it is not possible for the subject to become pregnant.

In some embodiments, where a filter is conditionally bypassed, one ormore supplemental filters may be used to better refine which subjectsare qualified for provision of the statin pharmaceutical composition.For example, as illustrated in example implementation 800, when thedevice determines the subject is a younger male with a family history ofpremature heart disease (e.g., as illustrated in steps 818 and 822 inFIG. 8B), filters relating to the calculation of an ASCVD risk (e.g.,the cholesterol filters, triglyceride filter, blood pressure filters,and pooled cohort equation filters at steps 824-850 as illustrated inFIG. 8) are bypassed because the ASCVD pooled cohort equation cannotcalculate an ASCVD risk for younger subjects. In some embodiments, thisis a better option than merely excluding all younger subjects, becausethose with a family history of premature heart disease are more likelyto develop premature heart disease themselves. However, it may bedesirable to evaluate these subjects for signs of premature heartdisease. For instance, as illustrated in steps 826-s and 830-s,supplemental LDL cholesterol and trigyceride filters are implemented asa replacement to similar bypassed filters. In this example, thesupplemental LDL cholesterol filter sets a higher floor LDL cholesterolthreshold of 160 mg/dL, rather than 70 mg/dL as used in the bypassed LDLcholesterol filter at step 826. The higher threshold in the supplementalfilter helps to eliminate subjects that have a family history ofpremature heart disease, but do not show indications of developingpremature heart disease themselves.

Age Filter

Referring to blocks 4016-4026 of FIG. 4B, in some embodiments the firstplurality of assessment filters 214-1 includes an age filter (e.g., agefilter 216-1 of FIG. 3A and/or filter 1 a in Table 2). In someembodiments, the age assessment filter is configured to be fired whenthe information set indicates that the subject fails to satisfy an agethreshold (e.g., when the subject is too young) to receive the statinpharmaceutical composition. Generally, the age threshold will be set ona jurisdiction-by-jurisdiction basis (e.g., a first subject in onegeographic region is of age to receive the statin pharmaceuticalcomposition while a second subject in another geographic region of thesame age is not permitted to receiving the statin pharmaceuticalcomposition). In some embodiments, the age threshold is 16 years of age.In some embodiments, the age threshold is 18 years of age. In someembodiments, the age threshold is 20 years of age. In some embodiments,the age threshold is at least 15, 16, 17, 18, 19, 20, 21, or more yearsof age.

In some embodiments, e.g., as in the embodiment illustrated in FIG. 8,the age threshold is set independently for men and women. For instance,in some embodiments, a first age threshold is set for men, e.g.,considering generally a safe age of maturity for administration of thestatin pharmaceutical agent, requiring the subject be at least 15, 16,17, 18, 19, 20, 21, or older. Similarly, in some embodiments, a secondage threshold is set for women, considering whether the woman is ofchild-bearing age, e.g., requiring that a woman is at least 45, 46, 47,48, 49, 50, 51, 52, 53, 54, 55, or older to be qualified for the statinpharmaceutical composition. Accordingly, in some embodiments, where anage threshold is set in order to exclude women of child-bearing age froma provision of the statin pharmaceutical agent, a pregnancy filter isexcluded from the workflow. However, in some embodiments, a pregnancyfilter is still included, despite use of a more restrictive agethreshold for women.

In some embodiments, the age filter is also configured to be fired whenthe first information indicates the subject fails to satisfy a ceilingage threshold (e.g., when the subject is too old). In some embodiments,the ceiling age threshold is 70 years old. In some embodiments, theceiling age threshold is 75 years old. In some embodiments, the ceilingage threshold is 80 years old. In other embodiments, the ceiling agethreshold is at least 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76,77, 78, 79, 80, 81, 82, 83, 84, 85, or older.

In some embodiments, e.g., when implemented as a first type of filter,when the age filter is fired, the subject is not permitted to obtainprovision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter (e.g., the method is terminated withoutauthorizing provision of the statin pharmaceutical composition to thesubject). In some embodiments, e.g., when implemented as a second typeof filter, when the age filter is fired, the subject is issued a warningassociated with the filter, but is eligible to obtain provision of thestatin pharmaceutical composition pharmaceutical compositionover-the-counter upon satisfying the acknowledgement criteria associatedwith the warning (e.g., by confirming that they have discussed the riskfactor with a medical professional and/or the medical professional hasadvised that the subject should take a statin pharmaceutical agentdespite the risk factor).

In some embodiments, age is also considered in combination with othercharacteristics of the subject in the information set. For example, insome embodiments, as illustrated at steps 818-820 in FIG. 8B, when thesubject has not experienced a cardiac event and does not have a familyhistory of premature cardiac disease, the device considers whether thesubject is still relatively young, e.g., aged 20-39, and terminates(803) the process by firing a filter in the first class of filters. Insome implementations of workflow 800, the process is terminated at thisstep because the pooled cohort equation used to evaluate the subject'sASCVD risk (e.g., a 10-year risk estimate for a hard ASCVD event usingthe pooled cohort equations provided in Goff, D C Jr. et al.,Circulation (2013) performed at step 844) cannot be applied to youngersubjects. Accordingly, when the subject does have a family history ofpremature coronary disease and is still relatively young, the systembypasses the pooled cohort equation filter at step 822. Similarly, asillustrated at steps 844-450 in FIG. 8E, in some embodiments, when thesubject has a moderate ASCVD risk and is diabetic, the system evaluateswhether the subject is older, e.g., at least 50 years old if a male andat least 60 years old if a female, and terminates the process (805)because of increased risks associated with statin use in olderdiabetics.

While these particular steps consider the age of the subject, they arenot necessarily tied to a dedicated age filter. Rather, they function tomore finely define which subjects would most benefit from statintherapy. For example, by facilitating eligibility for younger patientswith a family history of premature coronary disease, who would otherwisenot be eligible because of the limitations of the particular pooledcohort equation filter, and by safeguarding older diabetic patients thatare at higher risk for adverse events.

Accordingly, in some embodiments, one or more of these supplemental ageconsiderations are not included in the system, for instance, if allyounger patients are disqualified by an age-specific filter (e.g., atstep 808), if all diabetic patients are excluded or included, or if apooled cohort equation that can be applied to younger subjects are used.Alternatively, some or all of the supplemental age considerations can beintegrated as part of the age filter, e.g., at step 808.

Pregnancy Filter

Referring to blocks 4028-4030 of FIG. 4B, in some embodiments the firstplurality of assessment filters includes a pregnancy filter (e.g.,pregnancy filter 216-2 in FIG. 3A and/or filter 2 a in Table 2). Thepregnancy filter is configured to be fired at least when the firstinformation set indicates the subject is pregnant or breastfeeding. Insome embodiments, the pregnancy filter is also configured to be firedwhen the subject is planning to become pregnant. In some embodiments,the pregnancy filter is only applied when the information set indicatesthat the subject is female, e.g., the pregnancy filter is bypassed whenthe subject is male (e.g., as illustrated at steps 806-812 of workflow800 in FIG. 8A).

In some embodiments, e.g., when implemented as a first type of filter,when the pregnancy filter is fired, the subject is not permitted toobtain provision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter (e.g., the method is terminated withoutauthorizing provision of the statin pharmaceutical composition to thesubject). In some embodiments, e.g., when implemented as a second typeof filter, when the pregnancy filter is fired, the subject is issued awarning associated with the filter, but is eligible to obtain provisionof the statin pharmaceutical composition pharmaceutical compositionover-the-counter upon satisfying the acknowledgement criteria associatedwith the warning (e.g., by confirming that they have discussed the riskfactor with a medical professional and/or the medical professional hasadvised that the subject should take a statin pharmaceutical agentdespite the risk factor).

Severe Drug Interaction Filter

Referring to blocks 4032 through 4044 of FIG. 4C, in some embodiments,the first plurality of assessment filters includes a severe druginteraction filter (e.g., drug interaction filter 216-3 in FIG. 3 and/orfilter 3 a in Table 2). The severe drug interaction filter is configuredto be fired at least when the information set indicates that the subjectis taking one or more compositions that interacts with the statinpharmaceutical composition, e.g., a pharmacokinetic interaction and/or apharmacodynamic interaction, and is contraindicated forco-administration with the statin pharmaceutical composition.Non-limiting examples of drugs that may be contraindicated forco-administration with a statin pharmaceutical composition, e.g., basedon the particular statin, include cyclosporine, an anti-viral proteaseinhibitor, warfarin, a strong CYP3A4 inhibitor, and another cholesterollowering medication.

In some embodiments, e.g., when implemented as a first type of filter,when the severe drug interaction filter is fired, the subject is notpermitted to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject).

In some embodiments, e.g., when the statin pharmaceutical compositionincludes atorvastatin, fluvastatin, lovastatin, or pitavastatin as anactive ingredient, the severe drug interaction filter is configured tobe fired when the information set indicates that the subject is takingcyclosporine.

In some embodiments, e.g., when the statin pharmaceutical compositionincludes fluvastatin, lovastatin, or pravastatin as an activeingredient, the severe drug interaction filter is configured to be firedwhen the information set indicates the subject is already taking acholesterol-lowering medication or a triglyceride-lowering medication.

In some embodiments, e.g., when the statin pharmaceutical compositionincludes lovastatin, pitavastatin, or simvastatin as an activeingredient, the severe drug interaction filter is configured to be firedwhen the information set indicates the subject is taking an anti-viralprotease inhibitor.

In some embodiments, e.g., when the statin pharmaceutical compositionincludes fluvastatin as an active ingredient, the severe druginteraction filter is configured to be fired when the informationindicates the subject is taking warfarin.

In some embodiments, e.g., when the statin pharmaceutical compositionincludes lovastatin or simvastatin as an active ingredient, the severedrug interaction filter is configured to be filed when the informationset indicates the subject is taking a strong CYP3A4 inhibitor.

In some embodiments, e.g., when the statin pharmaceutical compositionincludes rosuvastatin as an active ingredient, the severe druginteraction filter is configured to be fired when the information setindicates the subject is taking cyclosporine, a cholesterol-loweringmedication, a triglyceride-lowering medication, or warfarin.

As will be appreciated, compositions that are contraindicated, orrepresent a risk factor, for co-administration with a statinpharmaceutical composition vary from one statin pharmaceuticalcomposition to another statin pharmaceutical composition. The skilledartisan will know, for example, of one or more compositions thatinteract with one statin pharmaceutical composition but not another.Inclusion of a composition within the severe drug interaction filter isdependent upon the identity and/or the dosage of the statinpharmaceutical composition being authorized for a provision ofover-the-counter use.

As described further below, in some embodiments, use a drug thatinteracts with a statin pharmaceutical composition in a less severefashion, e.g., which is a risk factor rather than a contraindication, issufficient to trigger firing of a filter 222 in the second filtercategory class 220 (e.g., a moderate drug interaction filter), ratherthan the severe drug interaction filter 216 of the first plurality ofassessment filters 214-1. For example, according to some embodiments, aparticular composition is included in the severe drug interaction filter216 (e.g., as a contraindication) for a first statin pharmaceuticalcomposition, but included in a filter in the second plurality ofassessment filters (e.g., as a risk factor) for a second statinpharmaceutical composition. A person skilled in the art will knowwhether to include a certain composition within the severe druginteraction filter 216-3 or as a separate filter 222 in the secondplurality of assessment filters (e.g., a moderate drug interactionfilter), based on the severity and risk of the drug interaction with theparticular identity and dosage of the statin being authorized forprovision of over-the-counter use.

Cardiac Event Filter

Referring to blocks 4046 through 4050 of FIG. 4D, in some embodimentsthe first plurality of assessment filters 214-1 includes a cardiac eventfilter (e.g., cardiac event filter 216-4 in FIG. 3A and/or filter 4 a inTable 2). In some embodiments, the cardiac event filter is configured tobe fired at least when the information set indicates the subject has hada documented cardiac event. In some embodiments, the cardiac eventfilter is fired when the first information set indicates the subject hashad a heart attack, had a stroke, undergone a heart procedure, ordeveloped peripheral artery disease (PAD). Examples of heart proceduresthat, in some embodiments, may fire the cardiac event filter includeopen-heart surgery, coronary artery bypass surgery, heart valvereplacement and/or repair, surgery to treat heart arrhythmia, aneurysmrepair surgery, coronary revascularization surgery, carotidendarterectomy, heart transplant, and the like.

In some embodiments, e.g., when implemented as a first type of filter,when the cardiac event filter is fired, the subject is not permitted toobtain provision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter (e.g., the method is terminated withoutauthorizing provision of the statin pharmaceutical composition to thesubject). In some embodiments, e.g., when implemented as a second typeof filter, when the cardiac event filter is fired, the subject is issueda warning associated with the filter, but is eligible to obtainprovision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter upon satisfying the acknowledgementcriteria associated with the warning (e.g., by confirming that they havediscussed the risk factor with a medical professional and/or the medicalprofessional has advised that the subject should take a statinpharmaceutical agent despite the risk factor).

Total Cholesterol Filter

Referring to blocks 4052 through 4058 of FIG. 4D, in some embodimentsthe first plurality of assessment filters includes a total cholesterolfilter (e.g., total cholesterol filter 216-5 in FIG. 3 and/or filter 5 ain Table 2). In some embodiments, the total cholesterol filter isconfigured to be fired at least when the information set indicates thesubject has a total cholesterol level that fails to satisfy a ceilingtotal cholesterol level threshold. For example, in some embodiments, thetotal cholesterol filter is fired when the first information setindicates the total cholesterol level of the subject is greater than 320milligrams per deciliter (mg/dL), e.g., where the ceiling totalcholesterol level threshold is 320 mg/dL. In other embodiments, theceiling total cholesterol level threshold is at least 250 mg/dL, atleast 275 mg/dL, at least 300 mg/dL, at least 325 mg/dL, or at least 350mg/dL.

In some embodiments, the total cholesterol filter is configured to befired, in addition to or instead of failing to satisfy a ceiling totalcholesterol threshold, when the first information set indicates thesubject has a total cholesterol level that fails to satisfy a floortotal cholesterol level threshold. For example, in some embodiments, thetotal cholesterol filter is fired when the first information setindicates the total cholesterol level of the subject is less than 130mg/dL, e.g., where the floor total cholesterol threshold is 130 mg/dL.In other embodiments, the ceiling total cholesterol level threshold isno more than 175 mg/dL, no more than 150 mg/dL, no more than 125 mg/dL,or no more than 100 mg/dL.

In some embodiments, the total cholesterol filter is bypassed undercertain conditions. For example, as illustrated in exampleimplementation 800, when the device determines the subject is a youngermale with a family history of premature heart disease (e.g., asillustrated in steps 818 and 822 in FIG. 8B), filters relating to thecalculation of an ASCVD risk (e.g., the cholesterol filters,triglyceride filter, blood pressure filters, and pooled cohort equationfilters at steps 824-850 as illustrated in FIG. 8) are bypassed becausethe ASCVD pooled cohort equation cannot calculate an ASCVD risk foryounger subjects. In some embodiments, a supplemental total cholesterolfilter is used where the standard total cholesterol filter is bypassed.

In some embodiments, e.g., when implemented as a first type of filter,when the total cholesterol filter is fired, the subject is not permittedto obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the total cholesterol filter is fired,the subject is issued a warning associated with the filter, but iseligible to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

LDL Cholesterol Filter

Referring to blocks 4060 through 4068 of FIG. 4E, in some embodimentsthe first plurality of assessment filters includes a low-densitylipoprotein (LDL) cholesterol filter (e.g., LDL cholesterol filter 216-6in FIG. 3 and/or filter 6 a in Table 2). In some embodiments, the LDLcholesterol filter is fired at least when the information set indicatesthe subject has a LDL cholesterol level that fails to satisfy a ceilingLDL cholesterol level threshold. For example, in some embodiments, theLDL cholesterol filter is fired when the first information set indicatesthe LDL cholesterol level of the subject is greater than 190 mg/dL,e.g., where the ceiling LDL cholesterol level threshold is 190 mg/dL. Inother embodiments, the ceiling LDL cholesterol level threshold is atleast 170 mg/dL, at least 180 mg/dL, at least 190 mg/dL, at least 200mg/dL, or at least 210 mg/dL.

In some embodiments, the total cholesterol filter is configured to befired, in addition to or instead of failing to satisfy a ceiling LDLcholesterol level threshold, when the first information set indicatesthe subject has a LDL cholesterol level that fails to satisfy a floorLDL cholesterol level threshold. For example, in some embodiments, theLDL cholesterol filter is fired when the first information set indicatesthe LDL cholesterol level of the subject is less than 70 mg/dL, e.g.,where the floor LDL cholesterol level threshold is 70 mg/dL. In otherembodiments, the LDL cholesterol level threshold is no more than 150mg/dL, no more than 125 mg/dL, no more than 100 mg/dL, no more than 90mg/dL, no more than 80 mg/dL, no more than 70 mg/dL, or no more than 60mg/dL.

In some embodiments, the LDL cholesterol filter is bypassed undercertain conditions. For example, as illustrated in exampleimplementation 800, when the device determines the subject is a youngermale with a family history of premature heart disease (e.g., asillustrated in steps 818 and 822 in FIG. 8B), filters relating to thecalculation of an ASCVD risk (e.g., the cholesterol filters,triglyceride filter, blood pressure filters, and pooled cohort equationfilters at steps 824-850 as illustrated in FIG. 8) are bypassed becausethe ASCVD pooled cohort equation cannot calculate an ASCVD risk foryounger subjects.

In some embodiments, a supplemental LDL cholesterol filter is used wherethe standard total cholesterol filter is bypassed. For instance, asillustrated in steps 826-s and 830-s, in some embodiments a supplementalLDL cholesterol filter is implemented as a replacement to the bypassedLDL cholesterol filter. In some embodiments, the thresholds for thesupplemental LDL filter are the same as the thresholds for the bypassedLDL cholesterol filter, e.g., a ceiling threshold of 160 mg/dL and afloor threshold of 70 mg/dL. In other embodiments, one or morethresholds in the supplemental LDL cholesterol filter are setdifferently. For instance, in some embodiments, the supplemental LDLcholesterol filter has a higher floor threshold, setting a more strictrequirement for obtaining provision of the statin pharmaceuticalcomposition. For example, in some embodiments, the floor threshold forthe supplemental LDL cholesterol threshold is 160 mg/dL. The higherthreshold in the supplemental filter helps to eliminate subjects thathave a family history of premature heart disease, but do not showindications of developing premature heart disease themselves. In otherembodiments, the floor threshold for the supplemental LDL cholesterolthreshold at least 90 mg/dL, at least 100 mg/dL, at least 125 mg/dL, atleast 150 mg/dL. In some embodiments, the ceiling threshold for the LDLcholesterol filter is the same as the ceiling threshold for the bypassedLSL cholesterol filter, e.g., 190 dL/mg.

In some embodiments, e.g., when implemented as a first type of filter,when the LDL cholesterol filter is fired, the subject is not permittedto obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the LDL cholesterol filter is fired,the subject is issued a warning associated with the filter, but iseligible to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

HDL Cholesterol Filter

Referring to blocks 4070 through 4076 of FIG. 4E, in some embodimentsthe first plurality of assessment filters includes a high-densitylipoprotein (HDL) cholesterol filter (e.g., HDL cholesterol filter 216-7in FIG. 3 and/or filter 7 a in Table 2). In some embodiments, the HDLcholesterol filter is configured to be fired at least when theinformation set indicates the subject has a HDL cholesterol level thatfails to satisfy a ceiling HDL cholesterol level threshold. For example,in some embodiments, the HDL cholesterol filter is fired when the firstinformation set indicates the HDL cholesterol level of the subject isgreater than 100 mg/dL, e.g., where the ceiling HDL cholesterol levelthreshold is 100 mg/dL. In other embodiments, the ceiling HDLcholesterol level threshold is at least 80 mg/dL, at least 90 mg/dL, atleast 100 mg/dL, at least 110 mg/dL, or at least 120 mg/dL.

In some embodiments, the HDL cholesterol filter is configured to befired, in addition to or instead of failing to satisfy a ceiling HDLcholesterol level threshold, when the first information set indicatesthe subject has a HDL cholesterol level that fails to satisfy a floorHDL cholesterol level threshold. For example, in some embodiments, theHDL cholesterol filter is fired when the first information set indicatesthe HDL cholesterol level of the subject is less than 20 mg/dL, e.g.,where the floor HDL cholesterol level threshold is 20 mg/dL. In otherembodiments, the ceiling total cholesterol level threshold is no morethan 10 mg/dL, no more than 15 mg/dL, no more than 20 mg/dL, no morethan 25 mg/dL, or no more than 30 mg/dL.

In some embodiments, the HDL cholesterol filter is bypassed undercertain conditions. For example, as illustrated in exampleimplementation 800, when the device determines the subject is a youngermale with a family history of premature heart disease (e.g., asillustrated in steps 818 and 822 in FIG. 8B), filters relating to thecalculation of an ASCVD risk (e.g., the cholesterol filters,triglyceride filter, blood pressure filters, and pooled cohort equationfilters at steps 824-850 as illustrated in FIG. 8) are bypassed becausethe ASCVD pooled cohort equation cannot calculate an ASCVD risk foryounger subjects. In some embodiments, a supplemental HDL cholesterolfilter is used where the standard total cholesterol filter is bypassed.

In some embodiments, e.g., when implemented as a first type of filter,when the HDL cholesterol filter is fired, the subject is not permittedto obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the HDL cholesterol filter is fired,the subject is issued a warning associated with the filter, but iseligible to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

Triglyceride Filter

Referring to blocks 4078 and 4080 of FIG. 4F, in some embodiments thefirst plurality of assessment filters includes a triglyceride filter(e.g., triglyceride filter 216-8 in FIG. 3 and/or filter 8 a in Table2). In some embodiments, the triglyceride filter is configured to befired when the when the information set indicates the subject has atriglyceride level that fails to satisfy a ceiling triglyceride levelthreshold. For example, in some embodiments, the triglyceride filter isfired when the information set indicates the triglyceride level of thesubject is greater than 500 mg/dL, e.g., where the ceiling triglyceridelevel threshold is 500 mg/dL. In other embodiments, the ceilingtriglyceride level threshold is at least 450 mg/dL, at least 475 mg/dL,at least 500 mg/dL, at least 525 mg/dL, or at least 550 mg/dL.

In some embodiments, the triglyceride filter is bypassed under certainconditions. For example, as illustrated in example implementation 800,when the device determines the subject is a younger male with a familyhistory of premature heart disease (e.g., as illustrated in steps 818and 822 in FIG. 8B), filters relating to the calculation of an ASCVDrisk (e.g., the cholesterol filters, triglyceride filter, blood pressurefilters, and pooled cohort equation filters at steps 824-850 asillustrated in FIG. 8) are bypassed because the ASCVD pooled cohortequation cannot calculate an ASCVD risk for younger subjects.

In some embodiments, a supplemental triglyceride filter is used wherethe standard triglyceride filter is bypassed. For instance, asillustrated in step 830-s, in some embodiments a supplementaltriglyceride filter is implemented as a replacement to the bypassedtriglyceride filter. In some embodiments, the threshold for thesupplemental triglyceride is the same as the thresholds for the bypassedtriglyceride filter, e.g., a ceiling threshold of 500 mg/dL, or at least450 mg/dL, at least 475 mg/dL, at least 500 mg/dL, at least 525 mg/dL,or at least 550 mg/dL. In other embodiments, the threshold in thesupplemental triglyceride filter is set differently than the thresholdfor the standard triglyceride filter.

In some embodiments, e.g., when implemented as a first type of filter,when the triglyceride filter is fired, the subject is not permitted toobtain provision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter (e.g., the method is terminated withoutauthorizing provision of the statin pharmaceutical composition to thesubject). In some embodiments, e.g., when implemented as a second typeof filter, when the triglyceride filter is fired, the subject is issueda warning associated with the filter, but is eligible to obtainprovision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter upon satisfying the acknowledgementcriteria associated with the warning (e.g., by confirming that they havediscussed the risk factor with a medical professional and/or the medicalprofessional has advised that the subject should take a statinpharmaceutical agent despite the risk factor).

Blood Pressure Filter

Referring to blocks 4082 through 4090 of FIG. 4F, in some embodimentsthe first plurality of assessment filters includes a blood pressurefilter (e.g., blood pressure filter 216-9 in FIG. 3 and/or filter 9 a inTable 2). In some embodiments, the blood pressure filter evaluates thesystolic blood pressure of the subject, the diastolic blood pressure ofthe subject, or both. In some embodiments, the rules underlying theblood pressure filter consider systolic and diastolic blood pressurereadings separately, e.g., setting separate criteria for firing thefilter. For example, as illustrated in example implementation 800 inFIG. 8D, the device first evaluates the systolic blood pressure of thesubject (at step 832) and then evaluates the diastolic blood pressure ofthe subject (at step 834). In other embodiments, the rules underlyingthe blood pressure filter consider systolic and diastolic blood pressureat a single step, e.g., requiring a particular combination of systolicand diastolic blood pressures in order to qualify to receive provisionof the statin pharmaceutical composition.

In some embodiments, the blood pressure filter is configured to be firedat least when the information set indicates that the systolic bloodpressure of the subject fails to satisfy a ceiling systolic bloodpressure threshold. For example, in some embodiments, the blood pressurefilter is configured to be fired when the first information setindicates the systolic blood pressure of the subject is greater than 180mmHg, e.g., where the ceiling systolic blood pressure threshold is 180mmHg. In other embodiments, the ceiling systolic blood pressurethreshold is at least 160 mmHg, at least 170 mmHg, at least 180 mmHg, atleast 190 mmHg, or at least 200 mmHg. In some embodiments, the bloodpressure filter is configured to be fired when the first information setindicates the subject is experiencing hypertensive crisis, e.g., asdetermined according to a set of healthcare guidelines, which may changeover time, and/or vary on a jurisdiction-by-jurisdiction basis. Forexample, in the United States, the American College of Cardiology andthe American Heart Association collaborated to provide guidance onmanagement of high blood pressure. Whelton P K, et al., J Am CollCardiol., S0735-1097(17)41519-1 (2017), the contents of which are herebyexpressly incorporated by reference.

In some embodiments, the blood pressure filter is configured to befired, in addition to or instead of failing to satisfy a ceilingsystolic blood pressure threshold, when the first information setindicates the subject has a systolic blood pressure that fails tosatisfy a floor systolic blood pressure threshold. For example, in someembodiments, the blood pressure filter is configured to be fired whenthe first information set indicates the systolic blood pressure of thesubject is less than 90 mmHg, e.g., where the floor systolic bloodpressure threshold is 90 mmHg. In other embodiments, the floor systolicblood pressure threshold is no more than 80 mmHg, no more than 90 mmHg,no more than 100 mmHg, no more than 110 mmHg, or no more than 120 mmHg.

In some embodiments, the blood pressure filter is configured to befired, in addition to or instead of failing to satisfy a systolic bloodpressure threshold, when the first information set indicates the subjecthas a diastolic blood pressure that fails to satisfy a ceiling diastolicblood pressure threshold. For example, in some embodiments, the bloodpressure filter is configured to be fired when the first information setindicates the diastolic blood pressure of the subject is greater than120 mmHg, e.g., where the ceiling diastolic blood pressure threshold is120 mmHg. In other embodiments, the ceiling diastolic blood pressurethreshold is at least 100 mmHg, at least 110 mmHg, at least 120 mmHg, orat least 130 mmHg. In some embodiments, the blood pressure filter isconfigured to be fired when the first information set indicates thesubject is experiencing hypertensive crisis, e.g., as determinedaccording to a set of healthcare guidelines, which may change over time,and/or vary on a jurisdiction-by-jurisdiction basis. For instance, theseguidelines change over time as medical research and advances intreatment better inform management of high blood pressure.

In some embodiments, the blood pressure filter is configured to befired, in addition to or instead of failing to satisfy any of the bloodpressure thresholds described above, when the first information setindicates the subject has a diastolic blood pressure that fails tosatisfy a floor diastolic blood pressure threshold. For example, in someembodiments, the blood pressure filter is configured to be fired whenthe first information set indicates the diastolic blood pressure of thesubject is less than 85 mmHg, e.g., where the floor diastolic bloodpressure threshold is 85 mmHg. In other embodiments, the floor diastolicblood pressure threshold is no more than 70 mmHg, no more than 80 mmHg,or no more than 90 mmHg.

In some embodiments, the blood pressure filter is bypassed under certainconditions. For example, as illustrated in example implementation 800,when the device determines the subject is a younger male with a familyhistory of premature heart disease (e.g., as illustrated in steps 818and 822 in FIG. 8B), filters relating to the calculation of an ASCVDrisk (e.g., the cholesterol filters, triglyceride filter, blood pressurefilters, and pooled cohort equation filters at steps 824-850 asillustrated in FIG. 8) are bypassed because the ASCVD pooled cohortequation cannot calculate an ASCVD risk for younger subjects. In someembodiments, a supplemental blood pressure filter is used where thestandard blood pressure filter is bypassed.

In some embodiments, e.g., when implemented as a first type of filter,when the blood pressure filter is fired, the subject is not permitted toobtain provision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter (e.g., the method is terminated withoutauthorizing provision of the statin pharmaceutical composition to thesubject). In some embodiments, e.g., when implemented as a second typeof filter, when the blood pressure filter is fired, the subject isissued a warning associated with the filter, but is eligible to obtainprovision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter upon satisfying the acknowledgementcriteria associated with the warning (e.g., by confirming that they havediscussed the risk factor with a medical professional and/or the medicalprofessional has advised that the subject should take a statinpharmaceutical agent despite the risk factor).

ASCVD Risk Filter

Referring to blocks 4092 through 4110 of FIGS. 4G and 4H, in someembodiments the first plurality of assessment filters includes anatherosclerotic cardiovascular disease (ASCVD) risk pooled cohortequation filter (e.g., ASCVD risk pooled cohort equation filter 216-10in FIG. 3 and/or filter 10 a in Table 2). In some embodiments, the ASCVDrisk pooled cohort equation filter is configured to be fired when thefirst information set indicates that the subject has a risk ofexperiencing a first hard ASCVD event, e.g., a nonfatal myocardialinfarction, coronary heart disease death, nonfatal stroke, or fatalstroke, within a given time period that fails to satisfy a ceiling ASCVDrisk threshold. In some embodiments, the ASCVD risk is calculated usinga pooled cohort equation, e.g., as explained in further detail below. Insome embodiments, the risk for the atherosclerotic cardiovasculardisease calculated using the pooled cohort equation is a 10-year ASCVDrisk. In other embodiments, the risk for the atheroscleroticcardiovascular disease calculated using the pooled cohort equation is5-year risk, a 15-year risk, a 20-year risk, or a lifetime risk (e.g.,or a period estimated to coincide with the subject's remaining estimatedlifetime (e.g., 25, 30, 40, 50, 60, or more years). In some embodiments,the pooled cohort equation is implemented as a multivariable Coxproportional hazard regression.

In some embodiments, the ASCVD risk for the subject is calculated as a10-year risk. In some embodiments, the pooled cohort equation filter isconfigured to be fired when the information set indicates the subjecthas a 10-year risk for a hard ASCVD event that is at least 20% (e.g., asdetermined by a pooled cohort equation), e.g., where the ceiling ASCVDrisk threshold is a 20% ten-year risk. In other embodiments, the ceilingASCVD risk threshold is at least a 15% ten-year risk, at least a 17.5%ten-year risk, at least a 20% ten-year risk, at least a 22.5% ten-yearrisk, or at least a 25% ten-year risk.

In some embodiments, the ASCVD risk pooled cohort equation filter isconfigured to be fired, in addition to or instead of failing to satisfya ceiling total cholesterol threshold, when the first information setindicates the subject has a hard ASCVD event risk that fails to satisfya floor ASCVD risk threshold. In some embodiments, the pooled cohortequation filter is configured to be fired when the information setindicates the subject has a 10-year risk for a hard ASCVD event that isless than 5%, e.g., where the floor ASCVD risk threshold is a 5%ten-year risk. In other embodiments, the floor ASCVD risk threshold isno more than a 2.5% ten-year risk, no more than a 5% ten-year risk, nomore than a 7.5% ten-year risk, or no more than a 10% ten-year risk.

In some embodiments, the system is configured to forgo firing of theASCVD risk pooled cohort equation filter—when the first information setindicates the subject has a hard ASCVD event risk that fails to satisfya floor ASCVD risk threshold—when the first information set indicatesthat additional risk factors are present that warrant further evaluatingthe subject for treatment with a statin pharmaceutical composition. Forexample, in some embodiments, when the subject is determined to have anASCVD risk falling below a floor ASCVD risk threshold, the systemevaluates whether the subject has diabetes and is not of an advanced age(e.g., as illustrated at steps 246 to 250 in FIG. 8H). Accordingly, insome embodiments, when the first information set indicates the subjecthas an ASCVD risk that fails to satisfy the ASCVD risk threshold, thesubject has diabetes, and the age of the subject satisfies a ceilingdiabetes age threshold for receiving the statin pharmaceuticalcomposition, the system forgoes firing the ASCVD risk pooled cohortequation filter. In some embodiments, the ceiling diabetes age thresholdis 45, 50, 55, 60, 65, or 70 years of age. In some embodiments, theceiling diabetes age threshold is set differently for man and women. Forinstance, in some embodiments, the ceiling diabetes age threshold is setto 50 years of age when the subject is a male and 60 years of age whenthe subject is a female. In some embodiments, the ceiling diabetes agethreshold is at least 45, at least 50, at least 55, or at least 60 for amale. In some embodiments, the ceiling diabetes age threshold is atleast 55, at least 60, at least 65, or at least 70 for a female.

In some embodiments, the ASCVD risk pooled cohort equation filter isconfigured to be fired—when the first information set indicates thesubject has a hard ASCVD event risk that satisfies both a ceiling ASCVDrisk threshold and a floor ASCVD risk threshold—when the firstinformation set indicates that additional risk factors are present thatwarrant limiting access to the statin pharmaceutical composition, orrequire more careful monitoring by a health care professional. Forexample, in some embodiments, when the subject is determined to have anASCVD risk falling between floor ASCVD risk threshold and a ceilingASCVD risk threshold—which would otherwise facilitate access to thestatin pharmaceutical composition—the system evaluates whether thesubject has diabetes and is of an advanced age (e.g., as illustrated atsteps 246-1 to 250 in FIG. 8E). Accordingly, in some embodiments, whenthe first information set indicates the subject has an ASCVD risk thatotherwise satisfies all ASCVD risk thresholds, but the subject hasdiabetes and an age failing to satisfy a ceiling diabetes age thresholdfor receiving the statin pharmaceutical composition, the system firesthe ASCVD risk pooled cohort equation filter. In some embodiments, theceiling diabetes age threshold is 45, 50, 55, 60, 65, or 70 years ofage. In some embodiments, the ceiling diabetes age threshold is setdifferently for man and women. For instance, in some embodiments, theceiling diabetes age threshold is set to 50 years of age when thesubject is a male and 60 years of age when the subject is a female. Insome embodiments, the ceiling diabetes age threshold is at least 45, atleast 50, at least 55, or at least 60 for a male. In some embodiments,the ceiling diabetes age threshold is at least 55, at least 60, at least65, or at least 70 for a female.

In some embodiments, the ASCVD risk pooled cohort equation filter isconfigured to be fired when one or more values in the first informationset does not enable calculation of an ASCVD event risk for the subject.For example, the ASCVD pooled cohort equation taught by Goff et al. isincalculable for subjects under the age of forty. Accordingly, in someembodiments when the Goff et al. equation is used, the ASCVD risk pooledcohort equation filter is configured to be fired when the firstinformation set indicates that subject is less than forty years old.Alternatively, in some embodiments, when a value in the firstinformation set does not enable calculation of an ASCVD event risk forthe subject, the ASCVD risk pooled cohort equation acts as a filter inthe second plurality of assessment filters 220-1. That is, when theASCVD risk pooled cohort equation filter determines that a value used tocalculate an ASCVD event risk is outside of the range required for thecalculation, the device issues a warning to the subject (e.g., requiringthe subject discuss taking a statin pharmaceutical composition with amedical professional) that must be acknowledged prior to beingauthorized a provision of the statin pharmaceutical composition, ratherthan automatically terminating the process, as would be done when thefilter acts as a filter in the first plurality of assessment filters214-1.

In other embodiments, the algorithm is configured such that one or morevalues falling outside of a range required for calculation of an ASCVDrisk trigger firing of a related filter, such that they do not need tobe considered when evaluating an ASCVD risk for the subject. Forexample, when the Goff et al. equation is used to calculate the ASCVDrisk evaluated by this filter, a risk cannot be calculated for subjectsyounger than forty years of age. Accordingly, in some embodiments, anage filter placed upstream of the ASCVD risk pooled cohort equation isconfigured to be fired if the first information set indicates thesubject is younger than forty years of age.

In some embodiments, the ASCVD risk pooled cohort equation filter isbypassed under certain conditions when one or more values fall outsideof a range required for calculation of an ASCVD risk. For example, asillustrated in example implementation 800 illustrated in FIG. 8, whenthe device determines the subject is younger than forty years ofage—such that an ASCVD risk cannot be calculated using the Goff et al.pooled cohort equation—the device determines whether the subject hasother risk factors that might warrant administration of a statinpharmaceutical composition. For instance, in some embodiments, a familyhistory of premature heart disease may warrant administering a statinpharmaceutical composition to a younger subject, despite that an ASCVDrisk cannot be calculated for the subject. In some embodiments, theyounger subject is a male, e.g., where younger females are disqualifiedbecause they are of child-bearing age. In some embodiments, the youngersubject is less than 45 years old. In some embodiments, the youngersubject is less than 40 years old. In some embodiments, the youngersubject is greater than 16 years of age. In some embodiments, theyounger subject is greater than 18 years of age. In some embodiments,the younger subject is greater than 20 years of age. In someembodiments, younger subject is from 20 years of age to 39 years of age.In other embodiments, the younger subject is from 16 years of age to 45years of age, 18 years of age to 45 years of age, 18 years of age to 40years of age, 20 years of age to 40 years of age, 20 years of age to 39years of age, or 21 years of age to 39 years of age. In someembodiments, the subject is considered to have a familial history ofpremature heart disease when a father or a brother of the subject had aheart attack or a stroke before the age of 55 years of age, or when amother or a sister of the subject had a heart attack or a stroke beforethe age of 65.

Accordingly, in some embodiments, e.g., as illustrated in steps 818 and822 in FIG. 8B, filters relating to the calculation of an ASCVD risk(e.g., the cholesterol filters, triglyceride filter, blood pressurefilters, and pooled cohort equation filters at steps 824-850 asillustrated in FIG. 8) are bypassed because the ASCVD pooled cohortequation cannot calculate an ASCVD risk for younger subjects. In someembodiments, one or more supplemental filters can be used in place ofthe bypassed filters, e.g., an LDL cholesterol filter, as implemented instep 826-s in FIG. 8H, and a triglyceride filter, as implemented in step830-s in FIG. 8H, to further evaluate whether the subject has additionalrisk factors that support providing the subject with provision of thestatin pharmaceutical composition.

In some embodiments, e.g., when implemented as a first type of filter,when the ASCVD risk pooled cohort equation filter is fired, the subjectis not permitted to obtain provision of the statin pharmaceuticalcomposition pharmaceutical composition over-the-counter (e.g., themethod is terminated without authorizing provision of the statinpharmaceutical composition to the subject). In some embodiments, e.g.,when implemented as a second type of filter, when the ASCVD risk pooledcohort equation filter is fired, the subject is issued a warningassociated with the filter, but is permitted to obtain provision of thestatin pharmaceutical composition pharmaceutical compositionover-the-counter when the acknowledgement criteria associated with thewarning (e.g., by confirming that they have discussed the risk factorwith a medical professional and/or the medical professional has advisedthat the subject should take a statin pharmaceutical agent despite therisk factor).

In some embodiments the ASCVD risk pooled cohort equation filterincorporates the age of the subject, the sex of the subject, the race ofthe subject, the total cholesterol of the subject, the triglyceridelevel of the subject, the systolic blood pressure of the subject, thediastolic blood pressure of the subject, whether the subject is taking amedication for hypertension, the diabetes status of the subject, and thesmoking status of the subject to derive a risk for atheroscleroticcardiovascular disease (e.g., a risk for experiencing an atheroscleroticcardiovascular disease (ASCVD) event within a certain timeframe, such aswithin five or ten years). In some embodiments, the pooled cohortequation also incorporates a familial history of premature heart orstroke (e.g., a familial history of heart attack or stroke before theage of forty-five, fifty, fifty-five, sixty, etc.). Accordingly, thefirst information set will include pertinent information required tocalculate an ASCVD risk, as defined by a particular pooled cohortequation for the risk.

The pooled cohort equation estimates the probability of incurring a hardatherosclerotic cardiovascular disease (ASCVD) event in a given periodof time, such as in the next 5 years, the next 10 years, or in thelifetime of a subject. In some embodiments, the pooled cohort equationfor the pooled cohort equation filter is calculated using the guidelinesset forth in Goff, D C Jr, et al., J. Am. Coll. Cardiol., 63:2935-59(2014), the content of which is hereby incorporated by reference.Following the Goff et al. (Id.) calculation of the 10-year risk estimatefor a hard ASCVD event using the pooled cohort equations is done as aseries of steps. The natural log of the age of the subject, totalcholesterol, HDL-C, and systolic blood pressure are first calculatedwith the systolic blood pressure being either a treated or untreatedvalue. For example, calculation of the pooled cohort equations estimatethe probability of a Caucasian male subject 55 years of age with totalcholesterol 213 mg/dL, HDL-C 50 mg/dL, untreated systolic blood pressure120 mm Hg, nonsmoker, and without diabetes determine the probability ofa hard ASCVD event in the next 10 years using Goff Id. begins by firsttaking the natural log of the subject's age (4.01), the natural log ofthe subject's total cholesterol (5.36), the natural log of the subject'sHDL-C (3.91), and the natural log of the subject's systolic bloodpressure (4.79). These values are then multiplied by the coefficientsfrom the equation (“Coefficient” column of Table A of Goff Id.) for thespecific race-gender group of the individual to obtain“coefficient×values.” That is:

-   -   multiply the natural log of the subject's age (4.01) by the        coefficient 12.344 to obtain the “coefficient×value” of 49.47,    -   multiply the natural log of the subject's total cholesterol        (5.36) by the coefficient 11.853 to obtain the        “coefficient×value” of 63.55,    -   multiply the natural log of the subject's HDL-C (3.91) by the        coefficient −7.990 to obtain the “coefficient×value” of −31.26,        and    -   multiply the natural log of the subject's systolic blood        pressure (4.79) by the coefficient 1.764 to obtain the        “coefficient×value” of 8.45.    -   Any appropriate interaction terms are also calculated. Following        Goff Id., in the case of the Caucasian male subject 55 years of        age, the interaction terms are:    -   the Log Age (4.01)×Log total Cholesterol (5.36) multiplied by        the coefficient −2.664 to obtain the “coefficient×value” of        −57.24 and    -   Log Age (4.01) X Log HDL-C (3.91) multiplied by the coefficient        1.769 to obtain the “coefficient×value” of 27.73.        The sum of these “coefficient×values” is then calculated for the        individual (49.47+63.55−31.26+8.45−57.24+27.73=60.69). The        estimated 10-year risk of a first hard ASCVD event is formally        calculated as 1 minus the baseline survival rate at 10 years for        the gender/race (in this example Caucasian male), raised to the        power of the exponent of the “Coefficient×Value” sum calculated        above minus the race (Caucasian) and gender (Male) specific        overall mean “Coefficient×Value” sum; or, in equation form:

1−0.9144^(e) ^((60.69−61.18))

where the number 0.9144 is the baseline survival rate at 10 years forCaucasian males from Goff Id., the number 60.69 is the“coefficient×value” calculated for the particular subject as detailedabove, and the number 61.18 is the race (Caucasian) and gender (Male)specific overall mean “Coefficient×Value” from Goff Id. This equates toa 5.3% probability of a first hard ASCVD event within 10 years.

In some embodiments, using the Goff et al. calculation, the risk for thefatal cardiovascular disease used in calculating the pooled cohortequation is a 10-year risk, and a first threshold value, e.g., athreshold value which when the risk of the subject is determined to beless than fires the filter, is about 10% risk. In some embodiments, therisk for the fatal cardiovascular disease used in calculating the pooledcohort equation is a 10-year risk, and the first threshold value is a10% risk.

In some embodiments, the pooled cohort equation filter incorporates someor all of the characteristics listed in Table 3, e.g., as determinedfrom a set of survey results, to derive a subject risk foratherosclerotic cardiovascular disease. For example, in someembodiments, the plurality of assessment survey results includes 2, 3,4, 5, 6, 7, 8, 9, 10, or all 11 of the characteristics listed in Table3. The pooled cohort equation filter is fired when the subject's riskfor atherosclerotic cardiovascular disease exceeds a threshold level ofrisk.

TABLE 3 Example Characteristics Used for Pooled Cohort Equation FilterResult Exemplary Characteristics 1 a gender of the subject 2 an age ofthe subject 3 a total cholesterol level of the subject 4 a HDLcholesterol count of the subject 5 a systolic blood pressure of thesubject 6 a race of the subject 7 whether the subject is taking one ormore medications for hypertension 8 a smoking status of the subject 9 adiabetes status of the subject 10 whether the subject has a familyhistory of heart or stroke before the age of 60 11 a hsCRP level of thesubject

In some embodiments, the pooled cohort equation used to calculate a riskof fatal cardiovascular disease for the pooled cohort equation filter iscalculated using the guidelines set forth in Perk J. et al., EuropeanGuidelines on cardiovascular disease prevention in clinical practice,European Heart Journal 33:1635-1701 (2012), which is hereby incorporatedby reference herein. In some embodiments, the pooled cohort equationassessment filter follows a low CVD risk SCORE chart, which incorporatesthe gender of the subject, the age of the subject, the total cholesterollevel of the subject, the systolic blood pressure of the subject, and asmoking status of the subject, as set forth in Perk J. et al., Supra. Insome embodiments, a conversion factor is used to convert a risk of fatalcardiovascular disease to a risk of fatal plus nonfatal hardcardiovascular disease events, as set forth in Catapano A L et al., 2016ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J.2016 Oct. 14; 37(39):2999-3058, which is hereby incorporated byreference herein. In one embodiment, the pooled cohort equation filterincorporates at least survey results 1-9 as provided in Table 3, e.g.,according to the method described in Goff, D C Jr, et al., J. Am. Coll.Cardiol., 63:2935-59 (2014). In another embodiment, the assessmentsurvey results include at least survey results 1-10 as provided in Table3. In another embodiment, the assessment survey results include at leastsurvey results 1-9 and 11 as provided in Table 3. In another embodiment,the assessment survey results include at least survey results 1-11 asprovided in Table 3.

In some embodiments, using the SCORE guidelines, the risk for the fatalcardiovascular disease used in calculating the pooled cohort equation isa 10-year risk, and a first threshold value, e.g., a threshold valuewhich when the risk of the subject is determined to be less than firesthe filter, is a 5% risk. In some embodiments, the risk for the fatalcardiovascular disease used in calculating the pooled cohort equation isa 10-year risk, and the first threshold value is a 10% risk.

In some embodiments, the pooled cohort equation used to calculate a riskof a cardiovascular disease-related death for the pooled cohort equationfilter is calculated using the guidelines set forth in Teramoto et al.,Japan Atherosclerosis Society. Executive summary of the JapanAtherosclerosis Society (JAS) guidelines for the diagnosis andprevention of atherosclerotic cardiovascular diseases in Japan-2012version, J Atheroscler Thromb., 2013; 20(6):517-23, which is herebyincorporated by reference herein. In some embodiments, the pooled cohortequation assessment filter follows the NIPPON DATA80 absolute riskassessment charts, which incorporate the gender of the subject, the ageof the subject, the total cholesterol level of the subject, the systolicblood pressure of the subject, and a smoking status of the subject, asset forth in Teramoto et al., Supra. In some embodiments, the pooledcohort equation also incorporates a glucose level of the subject.

In some embodiments, using the NIPPON DATA80 guidance, the risk for thecoronary artery death used in calculating the pooled cohort equation isa 10-year risk, and a first threshold value, e.g., a threshold valuewhich when the risk of the subject is determined to be less than firesthe filter, is a 0.5% risk. In some embodiments, the risk for the fatalcardiovascular disease used in calculating the pooled cohort equation isa 10-year risk, and the first threshold value is a 1% risk. In someembodiments, the risk for the fatal cardiovascular disease used incalculating the pooled cohort equation is a 10-year risk, and the firstthreshold value is a 2% risk. In other embodiments, the risk for thefatal cardiovascular disease used in calculating the pooled cohortequation is a 10-year risk, and the first threshold value is a 3%, 4%,or 5% risk.

In some embodiments, the pooled cohort equation used to calculate a riskof atherosclerotic cardiovascular disease for the pooled cohort equationassessment filter is calculated using the guidelines set forth in YangX. et al., Predicting the 10-Year Risks of AtheroscleroticCardiovascular Disease in Chinese Population: The China-PAR Project(Prediction for ASCVD Risk in China). Circulation. 2016 Nov. 8;134(19):1430-1440, which is hereby incorporated by reference herein. Insome embodiments, the pooled cohort equation assessment filter followsthe China-PAR gender specific equations, which incorporate the gender ofthe subject (e.g., to determine which equation to use), the age of thesubject, the systolic blood pressure of the subject, a blood pressuretreatment status of the subject, the total cholesterol level of thesubject, a smoking status of the subject, a diabetes mellitus status ofthe subject, the waist circumference of the subject, a geographicresidential-region of the subject (e.g., for Chinese residents only,either northern China or southern China), an urbanizationresidential-region of the subject (e.g., for men residing in China only,either urban or rural), and family history of atheroscleroticcardiovascular disease (e.g., for men only), as set forth in Yang X. etal., Supra and at Supplemental Information. In some embodiments, thepooled cohort equation also incorporates an HDL cholesterol level of thesubject and/or a cholesterol treatment status of the subject.

In some embodiments, using the China-PAR guidance, the risk for theatherosclerotic cardiovascular disease used in calculating the pooledcohort equation is a 10-year risk, and a first threshold value, e.g., athreshold value which when the risk of the subject is determined to beless than fires the filter, is a 5% risk. In some embodiments, the riskfor the atherosclerotic cardiovascular disease used in calculating thepooled cohort equation is a 10-year risk, and the first threshold valueis a 7.5% risk. In some embodiments, the risk for the atheroscleroticcardiovascular disease used in calculating the pooled cohort equation isa 10-year risk, and the first threshold value is a 7.5% risk.

In some embodiments, the pooled cohort equation used to calculate a riskof atherosclerotic cardiovascular disease for the pooled cohort equationassessment filter 216-5 is calculated using the guidelines set forth inNational Vascular Disease Prevention Alliance, Guidelines for themanagement of absolute cardiovascular disease risk, 2012, which ishereby incorporated by reference herein. In some embodiments, the pooledcohort equation assessment filter follows the Australian cardiovascularrisk charts, which incorporate the gender of the subject, the age of thesubject, the systolic blood pressure of the subject, the ratio of totalcholesterol to HDL levels of the subject, and a smoking status of thesubject, as set forth in Absolute cardiovascular disease riskmanagement: Quick reference guide for health professionals, 2012,National Stroke Foundation. In some embodiments, the pooled cohortequation also incorporates the decent of the subject (e.g., in Australiaonly, for Aboriginal, Tones Strait Islander, or other populations).

In some embodiments, using the Australian cardiovascular risk charts,the risk for the atherosclerotic cardiovascular disease used incalculating the pooled cohort equation is a 5-year risk, and a firstthreshold value, e.g., a threshold value which when the risk of thesubject is determined to be less than fires the filter, is a 5% risk. Insome embodiments, the risk for the atherosclerotic cardiovasculardisease used in calculating the pooled cohort equation is a 5-year risk,and the first threshold value is a 10% risk. In some embodiments, therisk for the atherosclerotic cardiovascular disease used in calculatingthe pooled cohort equation is a 5-year risk, and the first thresholdvalue is a 16% risk. In some embodiments, the risk for theatherosclerotic cardiovascular disease used in calculating the pooledcohort equation is a 5-year risk, and the first threshold value is a 20%risk. In some embodiments, the risk for the atheroscleroticcardiovascular disease used in calculating the pooled cohort equation isa 5-year risk, and the first threshold value is a 25% risk.

In some embodiments, the pooled cohort equation used to calculate a riskof atherosclerotic cardiovascular disease for the pooled cohort equationassessment filter 216-5 is calculated using the guidelines set forth inAnderson T J et al., 2016 Canadian Cardiovascular Society Guidelines forthe Management of Dyslipidemia for the Prevention of CardiovascularDisease in the Adult, Can J Cardiol. 2016 November; 32(11):1263-1282,which is hereby incorporated by reference herein. In some embodiments,the pooled cohort equation assessment filter follows a Framingham HeartStudy Risk Score equation (FRS), which incorporates the gender of thesubject, the age of the subject, the systolic blood pressure of thesubject, a blood pressure treatment status of the subject, the totalcholesterol level of the subject, and an HDL cholesterol level of thesubject, a smoking status of the subject, a diabetes mellitus status ofthe subject, and a CVD event incident status of the subject, as setforth in D′Agostino R B Sr et al., General cardiovascular risk profilefor use in primary care: the Framingham Heart Study. Circulation. 2008Feb. 12; 117(6):743-53, which is hereby incorporated by referenceherein. In some embodiments, the pooled cohort equation assessmentfilter follows a modified Framingham Heart Study Risk Score equation(FRS), which incorporates the gender of the subject, the age of thesubject, the systolic blood pressure of the subject, a blood pressuretreatment status of the subject, the total cholesterol level of thesubject, and an HDL cholesterol level of the subject, a smoking statusof the subject, a diabetes mellitus status of the subject, and a CVDevent incident status of the subject, and a family history status ofpremature cardiovascular disease, as set forth in Anderson T J et al.,Supra. In some embodiments, the pooled cohort equation assessment filterfollows a Cardiovascular Life Expectancy Model (CLEM), as set forth inGrover S A et al., Estimating the benefits of modifying risk factors ofcardiovascular disease: a comparison of primary vs secondary prevention.Arch Intern Med. 1998 Mar. 23; 158(6):655-62, which is herebyincorporated by reference herein.

In some embodiments, using the Canadian Cardiovascular Society guidance,the risk for the atherosclerotic cardiovascular disease used incalculating the pooled cohort equation is a 10-year risk, and a firstthreshold value, e.g., a threshold value which when the risk of thesubject is determined to be less than fires the filter, is a 5% risk. Insome embodiments, the risk for the atherosclerotic cardiovasculardisease used in calculating the pooled cohort equation is a 10-yearrisk, and the first threshold value is a 10% risk. In some embodiments,the risk for the atherosclerotic cardiovascular disease used incalculating the pooled cohort equation is a 10-year risk, and the firstthreshold value is a 15% risk.

In some embodiments, a probability of the occurrence of a hard ASCVDevent in a given period of time (e.g., within the next 10 years), e.g.,as calculated above, is modified by considering one or both of thefamilial history of the subject for premature heart attacks or strokesand the hsCRP level of the subject. This inclusion is to reduce alikelihood of over-predicting adverse events, e.g., in subjects withouta familial history of adverse events and/or with healthy hsCRP levels.

Liver Condition Filter

Referring to block 4112 of FIG. 4H, in some embodiments the firstplurality of assessment filters includes a liver condition filter (e.g.,liver condition filter 216-11 in FIG. 3A and/or filter 11 a of Table 2).In some embodiments, the liver condition filter is configured to befired when the first information set indicates that the subject has anadverse liver condition. In some embodiments, an adverse liver conditionthat is capable of firing the liver condition filter includes symptomsand/or conditions such as inflammation of the liver, fibrosis,cirrhosis, end-stage liver disease (ESLD), cancer of the liver, and/orliver failure. In some embodiments, when the liver condition filter isfired, the subject is provided a recommendation to discuss taking alower dosage of the statin pharmaceutical composition with a medicalpractitioner.

In some embodiments, e.g., when implemented as a first type of filter,when the liver condition filter is fired, the subject is not permittedto obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the liver condition filter is fired,the subject is issued a warning associated with the filter, but iseligible to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

Risk Enhancing Factor Filter

Referring to blocks 4114 through 4132 of FIGS. 4H through 4J, in someembodiments the plurality of assessment filters includes a riskenhancing factor filter (e.g., filter 12 a of Table 2). In someembodiments, the risk enhancing factor filter is fired unless the firstinformation set indicates that the subject has at least one of aplurality of enhancing factors for high cholesterol. In someembodiments, the risk enhancing factor filter is fired unless the firstinformation set indicates that the subject has at least two of aplurality of enhancing factors for high cholesterol. In someembodiments, the risk enhancing factor filter is fired unless the firstinformation set indicates that the subject has at least three of aplurality of enhancing factors for high cholesterol. In otherembodiments, the risk enhancing factor filter is fired unless the firstinformation set indicates that the subject has at least four, five, six,or more of a plurality of enhancing factors for high cholesterol. Insome embodiments, the risk enhancing factors that prevent firing of therisk enhancing factor filter include one or more of South Asian descent(e.g., from Afghanistan, Bangladesh, Bhutan, India, Maldives, Pakistan,Nepal or Sri Lanka), a familial history of premature heart disease, anelevated LDL cholesterol level, an elevated triglyceride level, achronic kidney disease, an inflammatory disease (e.g., rheumatoidarthritis, psoriasis, or HIV/AIDS), a history of preeclampsia, prematuremenopause (e.g., before 35, 40, or 45 years of age), an elevatedC-Reactive Protein level, the presence of coronary artery calcium (e.g.,any coronary artery calcium), an elevated lipoprotein (a) level, anelevated apoB level, a low ankle-brachial index, and metabolic syndrome.

In some embodiments, a subject has a familial history of premature heartdisease when a father or a brother of the subject had a heart attack ora stroke before the age of 55 years of age, or when a mother or a sisterof the subject had a heart attack or a stroke before the age of 65. Insome embodiments, a subject has a familial history of premature heartdisease when a father or a brother of the subject had a heart attack ora stroke before the age of 50 years of age, 55 years of age, or 60 yearsof age. In some embodiments, a subject has a familial history ofpremature heart disease when a mother or a sister of the subject had aheart attack or a stroke before the age of 60 years of age, 65 years ofage, or 70 years of age.

In some embodiments, a subject has an elevated LDL cholesterol levelwhen their LDL cholesterol level is at least 160 mg/dL. In someembodiments, a subject has an elevated LDL cholesterol level when theirLDL cholesterol level is between about 160 and about 189 mg/dL. In otherembodiments, a subject has elevated LDL cholesterol when their LDLcholesterol level is at least 140 mg/dL, at least 150 mg/dL, at least170 mg/dL, or at least 180 mg/dL. In some embodiments, for the purposesof the methods described herein, a subject has an elevated LDLcholesterol level when their non-HDL-C level is at least 190 mg/dL. Insome embodiments, a subject has an elevated LDL cholesterol level whentheir non-HDL-C level is between about 190 and about 219 mg/dL. In otherembodiments, a subject has elevated LDL cholesterol when their non-HDL-Clevel is at least 170 mg/dL, at least 180 mg/dL, at least 190 mg/dL, atleast 200 mg/dL, or at least 210 mg/dL.

In some embodiments, a subject has an elevated triglyceride level whentheir triglyceride level is at least 175 mg/dL. In other embodiments, asubject has an elevated triglyceride level when their triglyceride levelis at least 150 mg/dL, at least 160 mg/dL, at least 170 mg/dL, at least180 mg/dL, at least 190 mg/dL, or at least 200 mg/dL. In someembodiments, a subject has kidney disease when they have an estimated

Glomerular Filtration Rate (eGFR) of less than about 60 mL/min/1.73 m².In other embodiments, a subject has kidney disease when they have anestimated Glomerular Filtration Rate of less than about 70, 65, 55, 50,or 45 mL/min/1.73 m². In some embodiments, chronic kidney disease isclassified as meeting the kidney disease requirement (e.g., having lessthan a threshold eGFR level) for at least two months. In someembodiments, chronic kidney disease is classified as meeting the kidneydisease requirement (e.g., having less than a threshold eGFR level) forat least three months. In some embodiments, e.g., where a particularstatin pharmaceutical agent is contraindicated for use in a subject withkidney disease, chronic kidney disease is not used as a risk enhancingfactor filter.

In some embodiments, a subject has an elevated C-Reactive Protein levelwhen their C-Reactive Protein level is at least 2 mg/dL. In otherembodiments, a subject has an elevated C-Reactive Protein level whentheir C-Reactive Protein level is at least 1 mg/dL, at least 1.5 mg/dL,at least 2.5 mg/dL, or at least 3 mg/dL.

In some embodiments, the presence of any coronary artery calciumconstitutes a risk enhancing factor. In other embodiments, the presenceof at least a threshold amount of coronary artery calcium constitutes arisk enhancing factor. For instance, in some embodiments, the thresholdlevel is set at a preselected Agatston score, e.g., of at least 5, 10,11, 20, 25, or more. In one embodiment, the threshold level is anAgatston score of at least 11. In some embodiments, a range of Agatstonscores is used to identify a risk enhancing factor, e.g., where a scorebelow the range does not constitute a risk enhancing factor and a scoreabove the range fires a filter, preventing the subject from obtainingthe statin pharmaceutical composition and recommending the subjectconsult a physician. For instance, in some embodiments, the range isfrom 1 to 400. In some embodiments, the range is from 1 to 100. In otherembodiments, the range is from about 10 to about 400, or about 10 toabout 100. The skilled artisan will know how to select an appropriaterange for a particular statin composition and dosage.

In some embodiments, the subject has an elevated lipoprotein (a) levelwhen their lipoprotein (a) level is at least 50 mg/dL (about 125nmol/L). In other embodiments, an elevated lipoprotein (a) level is atleast 40 mg/dL, at least 45 mg/dL, at least 55 mg/dL, or at least 60mg/dL.

In some embodiments, the subject has an elevated apoB level when theirapoB level is at least 130 mg/dL. In other embodiments, an elevated apoElevel is at least 110 mg/dL, at least 120 mg/dL, at least 140 mg/dL, orat least 150 mg/dL.

In some embodiments, the subject has a low ankle-brachial index whentheir ankle-brachial index is less than 0.9. On other embodiments, a lowankle-brachial index is less than 1.1, less than 1.0, less than 0.8, orless than 0.7. In some embodiments, a range of ankle-brachial index isused to identify a risk enhancing factor, e.g., where a score above therange does not constitute a risk enhancing factor and a score below therange fires a filter, preventing the subject from obtaining the statinpharmaceutical composition and recommending the subject consult aphysician. For instance, in some embodiments, the range is from about0.4 to about 0.9. In other embodiments the range starts between about0.3 and about 0.6 and ends between about 0.7 and ends about 1.1. Theskilled artisan will know how to select an appropriate range for aparticular statin composition and dosage.

Metabolic syndrome is a cluster of conditions that occur together,increasing the risk of heart disease, stroke, and type 2 diabetes. Insome embodiments, a subject is deemed to have metabolic syndrome whenthe information set indicates the subject has at least two indicators ofmetabolic syndrome. In some embodiments, the subject is deemed to havemetabolic syndrome when the information set indicates the subject has atleast three indicators of metabolic syndrome. In some embodiments, thesubject is deemed to have metabolic syndrome when the information setindicates the subject has at least four indicators of metabolicsyndrome. In some embodiments, the indicators of metabolic syndromeinclude one or more of an elevated waist circumference, an elevatedserum triglyceride level, a reduced HDL cholesterol level, an elevatedblood pressure, and an elevated fasting glucose level. That is, in someembodiments, the subject is deemed to have metabolic syndrome when theinformation set indicates that the subject has a plurality (e.g., two,three, four, or more) of elevated waist circumference, an elevated serumtriglyceride level, reduced HDL cholesterol level, elevated bloodpressure, and an elevated fasting glucose level.

Generally, the threshold for a waist circumference that is an indicatorof metabolic syndrome is determined differently for men and women. Forexample, in some embodiments, a waist circumference of at least 40inches indicates that a man has a metabolic syndrome while a waistcircumference of at least 35 inches indicates that a woman has ametabolic syndrome (e.g., where the predetermined threshold is set at 40inches for men and 35 inches for women). In some embodiments, thepredetermined threshold for men's waist circumference is at least 38inches, at least 39 inches, at least 40 inches, at least 41 inches, orat least 42 inches. In some embodiments, the predetermined threshold forwomen's waist circumference is at least 33 inches, at least 34 inches,at least 35 inches, at least 36 inches, or at least 37 inches.

In some embodiments, an HDL cholesterol level of less than 40 mg/dL isan indicator that the subject has a metabolic syndrome. In otherembodiments, an HDL cholesterol level of less than 50 mg/dL, less than45 mg/dL, less than less than 40 mg/dL, less than 35 mg/dL, or less than30 mg/dL, is an indication that the subject has a metabolic syndrome.

In some embodiments, a triglyceride level of greater than 150 mg/dL isan indicator that the subject has a metabolic syndrome. In otherembodiments, a triglyceride level of greater than 125 mg/dL, greaterthan 150 mg/dL, greater than 175 mg/dL, or greater than 200 mg/dL, is anindicator that the subject has a metabolic syndrome.

In some embodiments, an HDL cholesterol level of less than 50 mg/dL isan indicator that the subject has a metabolic syndrome. In someembodiments, an HDL cholesterol level of less than 40 mg/dL is anindicator that the subject has a metabolic syndrome. In otherembodiments, an HDL cholesterol level of less than 55 mg/dL, less than45 mg/dL, or less than 35 mg/dL is an indicator that the subject has ametabolic syndrome. In some embodiments, the threshold for an HDLcholesterol level that is an indicator of metabolic syndrome isdetermined differently for men and women. For example, in someembodiments, an HDL cholesterol level of less than 40 mg/dL indicatesthat a man has a metabolic syndrome while an HDL cholesterol level ofless than 50 mg/dL indicates that a woman has a metabolic syndrome. Insome embodiments, the threshold for men's HDL cholesterol level is lessthan 50 mg/dL, less than 45 mg/dL, less than 35 mg/dL, or less than 30mg/dL. In some embodiments, the threshold for women's HDL cholesterollevel is less than 60 mg/dL, less than 55 mg/dL, less than 45 mg/dL, orless than 40 mg/dL.

In some embodiments, a subject's blood pressure is an indicator that thesubject has metabolic disease when either the subject's systolic bloodpressure or the subject's diastolic blood pressure is above apredetermined threshold. In some embodiments, the predeterminedthreshold for a systolic blood pressure is at least 130 mm Hg. In otherembodiments, the predetermined threshold for a systolic threshold is atleast 120 mm Hg, at least 125 mm Hg, at least 135 mm Hg, or at least 14mmHg. In some embodiments, the predetermined threshold for a diastolicblood pressure is at least 85 mmHg. In other embodiments, thepredetermined threshold for a diastolic blood pressure is at least 75 mmHg, at least 80 mm Hg, at least 90 m Hg, or at least 95 Hg. Generally,if both of a subject's systolic and diastolic blood pressures satisfy apredetermined threshold, a single indicator of metabolic disease iscounted. However, in other embodiments, each would be counted as aseparate indicator.

In some embodiments, a fasting glucose level of at least 100 mg/dL is anindicator that the subject has a metabolic syndrome. In otherembodiments, a fasting glucose level of greater than 80 mg/dL, greaterthan 90 mg/dL, greater than 110 mg/dL, or greater than 120 mg/dL, is anindicator that the subject has a metabolic syndrome.

Referring to block 4134 of FIG. 4J, in some embodiments the method alsoincludes using the algorithm to run all or a portion of the informationset against a second plurality of assessment filters 220-1. When arespective filter in the second plurality of assessment filters 220-1 isfired, the subject is provided with a warning 226 corresponding to therespective filter (e.g., filter warning 228-4 corresponds to filter222-4). In some embodiments, the warning 226 is provided as a next step,e.g., prior to applying the algorithm the information set or anysubsequent filters, after the corresponding filter is fired. Forexample, with respect to FIG. 8F, in some embodiments, e.g., when thealcohol consumption filter is triggered at 856, the device would providethe subject with a warning prior to proceeding to the adverse reactionfilter at 858, e.g., requiring the subject confirm the warning (e.g.,confirming they have discussed their alcohol consumption status with ahealth care provider and the healthcare provider still recommends takinga statin pharmaceutical composition) prior to continuing. In someembodiments, the warning 226 is provided at a later time, e.g., afterapplying the information set to all subsequent filters, but prior toqualifying the subject for access to the statin pharmaceutical agent.For example, as illustrated in FIG. 8F, in some embodiments, e.g whenthe alcohol consumption filter is triggered at 856, the device wouldproceed to the adverse reaction filter at 858 prior to transmitting awarning to the subject, and then transmit all warnings corresponding tofilters of the second plurality of filters 220-1, at 884 and/or 886,after the algorithm has applied the information set all subsequentfilters.

For example, in some embodiments, the device transmits a prompt toprovide information about a possible risk factor for statin use (e.g.,prompt 654 “Do you have a history of kidney disease?,” as illustrated inFIG. 6C), receives a response to the prompt, and then applies analgorithm to the response provided by the subject (e.g., through akidney disease filter as described below).

When the response indicates that a triggering condition has been met(e.g., the subject has a history of kidney disease), the filter is firedand the device transmits a warning associated with the filter to thesubject. If the subject confirms the warning, the subject is stilleligible to receive provision of the statin pharmaceutical agent. If thesubject does not confirm the warning, the process is terminated withoutauthorizing provision of the statin pharmaceutical composition to thesubject. For example, FIG. 6D illustrates an example warning 656provided to a subject who clicked “Yes” in response to prompt 654,asking whether they have discussed taking a statin with their doctor inview of their history of kidney disease. In some embodiments, thewarning includes a message explaining the risk factor. For instance,warning 656 tells the subject that users with compromised kidneyfunction may experience adverse effects when taking a statin.

Referring to blocks 4134-4152 of FIGS. 4J-4K, example assessment filters222 in the second plurality of assessment filters 220 and exampletriggering conditions 224 that cause the corresponding assessmentfilters to fire are described.

TABLE 4 Example Filters of the Second Plurality of Assessment FiltersFilter Example Criteria 1b an alcohol consumption filter 2b a firstadverse reaction filter 3b a moderate drug interaction filter 4b asecond adverse reaction filter 5b a kidney disorder filter

In some embodiments, the second plurality of assessment filters 220includes some or all of the filters 222 listed in Table 4. For example,in some embodiments, the second plurality of assessment filters 220includes 2, 3, 4, or all 5 of the filters listed in Table 4. In oneembodiment, the second plurality of assessment filters includes at leastfilters 1 b-3 b as provided in Table 4. In some embodiments, e.g., wherethe particular statin pharmaceutical agent is primarily eliminated byrenal excretion, the second plurality of assessment filters furtherincludes a kidney disorder filter 5 b. Thus, in some embodiments, thesecond plurality of assessment filters includes at least filters 1 b-3 band 5 b as provided in Table 4. In some embodiments, a second adversedrug reaction filter that is specific for adverse reactions against theparticular statin compound being provided is implemented, e.g., in placeof or in addition to the first adverse reaction filter which refers moregenerally to cholesterol-lowering medications. Accordingly, in someembodiments, the second plurality of assessment filters includes atleast filters 1 b, 3 b and 4 b as provided in Table 4.

Accordingly, it is contemplated that in some embodiments the secondplurality of assessment filters includes any sub-set of filters 222provided in Table 4. Likewise, in some embodiments the skilled artisanmay know of other filters 222, not are provided in Table 4, which may becombined with any subset of the filters 222 provided in Table 4 to formthe second plurality of assessment filters and corresponding informationset used in the methods described herein. For brevity, all possiblecombinations of the assessment filters 222 provided in Table 4 are notspecifically delineated here.

It is contemplated that, in some embodiments, any one or more of thefilters provided in Table 4 will not be included in the second pluralityof assessment filters. For example, in some embodiments, acharacteristic associated with a portion of an information set will beinformative when qualifying a subject for one particular statinpharmaceutical composition but not for another statin pharmaceuticalcomposition. In some embodiments, one or more of the filters 222provided in Table 4 is implemented as a first type filter (e.g.,included in a first plurality of assessment filters), as describedabove, which automatically terminates the process without authorizingprovision of the statin pharmaceutical composition when fired. Forexample, in some cases, the decision to implement one of the filterslisted in Table 4 as a first type filter will be based on aconsideration specific to a particular statin compound and/or dosage ofthe statin compound. Similarly, in other cases, the decision toimplement one of the filters listed in Table 4 as a first type filterwill be based on a change in health and/or regulatory guidelines.

Alcohol Consumption Filter

Referring to blocks 4136 and 4138, in some embodiments the secondplurality of assessment filters 220 includes an alcohol consumptionfilter (e.g., alcohol consumption filter 222-1 in FIG. 3B and/or filter1 b in Table 4). The alcohol consumption filter is configured to befired at least when the information set indicates that the alcoholconsumption status of the subject fails to satisfy a ceiling alcoholconsumption threshold. In some embodiments, the ceiling alcoholconsumption threshold is an average daily consumption. For instance, insome embodiments, the ceiling alcohol consumption threshold is anaverage daily consumption of no more than two alcoholic drinks. That is,in such embodiments, the alcohol consumption filter is configured to befired when the information set indicates the subject consumes three ormore alcoholic drinks per day. In other embodiments, the ceiling alcoholconsumption threshold is an average daily consumption of no more thanone alcoholic drink, no more than three alcoholic drinks, or no morethan four alcoholic drinks. In some embodiments, the alcohol consumptionfilter is also configured to be fired when the information set indicatesthe subject partakes in binge drinking more frequently than a thresholdfrequency, e.g., at least once a week, at least 2, 3, 4, 5, 6, or moretimes per month.

In some embodiments, e.g., when implemented as a first type of filter,when the alcohol consumption filter is fired, the subject is notpermitted to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the alcohol consumption filter isfired, the subject is issued a warning associated with the filter, butis eligible to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

First Adverse Reaction Filter

Referring to block 4140 of FIG. 4J, in some embodiments the secondplurality of assessment filters 220-1 includes a first adverse reactionfilter (e.g., first adverse reaction filter 222-2 in FIG. 3B and/orfilter 2 b in Table 4). The first adverse reaction filter is configuredto be fired at least when the information set indicates that the subjecthas had an adverse reaction to a cholesterol-lowering drug.

In some embodiments, e.g., when implemented as a first type of filter,when the first adverse reaction filter is fired, the subject is notpermitted to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the first adverse reaction filter isfired, the subject is issued a warning associated with the filter, butis eligible to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

Moderate Drug Interaction Filter

Referring to block 4142 and 4144 of FIG. 4K, in some embodiments thesecond plurality of assessment filters 220-1 includes a moderate druginteraction filter (e.g., moderate drug interaction filter 222-3 in FIG.3B and/or filter 3 b in Table 4). The moderate drug interaction filteris configured to be fired at least when the information set indicatesthat the subject is taking one or more compositions that interacts withthe statin pharmaceutical composition, e.g., a pharmacokineticinteraction and/or a pharmacodynamic interaction, but is not necessarilycontraindicated for co-administration with the statin pharmaceuticalcomposition. For example, a composition associated with a warning forco-administration with the statin pharmaceutical composition.Non-limiting examples of drugs that may be associated with warnings whenco-administered with a statin pharmaceutical composition, e.g., based onthe particular statin, include colchicine and an anti-viral proteaseinhibitor.

In some embodiments, e.g., when implemented as a second type of filter,when the moderate drug interaction filter is fired, the subject isissued a warning associated with the filter, but is eligible to obtainprovision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter upon satisfying the acknowledgementcriteria associated with the warning (e.g., by confirming that they havediscussed the risk factor with a medical professional and/or the medicalprofessional has advised that the subject should take a statinpharmaceutical agent despite the risk factor).

As will be appreciated, compositions that are contraindicated, orrepresent a risk factor, for co-administration with a statinpharmaceutical composition vary from one statin pharmaceuticalcomposition to another statin pharmaceutical composition. The skilledartisan will know, for example, of one or more compositions thatinteract with one statin pharmaceutical composition but not another.Inclusion of a composition within the moderate drug interaction filteris dependent upon the identity and/or the dosage of the statinpharmaceutical composition being authorized for a provision ofover-the-counter use.

As described above, in some embodiments, use a drug that interacts witha statin pharmaceutical composition in a more severe fashion, e.g.,which is a contraindication, may trigger firing of a filter 216 in thefirst filter category class 214 (e.g., a severe drug interactionfilter), rather than the moderate drug interaction filter 222 of thesecond plurality of assessment filters 220-1. For example, according tosome embodiments, a particular composition is included in the severedrug interaction filter 216 (e.g., as a contraindication) for a firststatin pharmaceutical composition, but included in a filter in thesecond plurality of assessment filters (e.g., as a risk factor) for asecond statin pharmaceutical composition. A person skilled in the artwill know whether to include a certain composition within the severedrug interaction filter 216-3 or as a separate filter 222 in the secondplurality of assessment filters (e.g., a moderate drug interactionfilter), based on the severity and risk of the drug interaction with theparticular identity and dosage of the statin being authorized forprovision of over-the-counter use.

Second Adverse Reaction Filter

Referring to block 4146 of FIG. 4K, in some embodiments the secondplurality of assessment filters 220-1 includes a second adverse reactionfilter (e.g., filter 4 b in Table 4). The second adverse reaction filteris configured to be fired at least when the information set indicatesthat the subject has had an adverse reaction to the active ingredient ofthe statin pharmaceutical composition under consideration.

In some embodiments, e.g., when implemented as a first type of filter,when the second adverse reaction filter is fired, the subject is notpermitted to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the second adverse reaction filter isfired, the subject is issued a warning associated with the filter, butis eligible to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

Kidney Disorder Filter

Referring to blocks 4150 and 4152 of FIG. 4K, in some embodiments thesecond plurality of assessment filters includes a kidney disorder filter(e.g., filter 5 b in Table 4). For instance, in some embodiments whenthe statin pharmaceutical composition includes rosuvastatin,atorvastatin, fluvastatin, and/or pitavastatin, the algorithm appliesthe kidney condition filter to the information set. The kidney disorderfilter is configured to be fired at least when the information setindicates that the subject has had a kidney problem (e.g., has hadkidney disease). In some embodiments, the kidney disorder filter isconfigured to be fired at least when the information set indicates thatthe subject has been diagnosed with kidney disease. In some embodiments,symptoms of a kidney problem capable of firing the kidney disorderfilter include fatigue, a feeling of coldness, shortness of breath, afeeling of faintness, dizziness, weakness, a feeling of itchiness,and/or swelling of the hands and feet.

In some embodiments, e.g., when implemented as a first type of filter,when the kidney disorder filter is fired, the subject is not permittedto obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the kidney disorder filter is fired,the subject is issued a warning associated with the filter, but iseligible to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

The skilled artisan may know of other filters that could be implementedas second type filters. For example, in some embodiments, a South Asiandecent filter could be implemented, e.g., when the statin compound underconsideration is associated with an increased risk of adverse reactionsin persons of South Asian descent. In some embodiments, South Asiandescent refers to ancestry from a country on the Indian sub-continent,e.g., Indian, Afghani, Pakistani, or Bangladeshi descent, e.g., asopposed to ancestry from an Asian country not on the Indiansub-continent, e.g., Japanese, Pilipino, Chinese, or Korean descent.

Referring to block 4154 of FIG. 4L, in some embodiments the warning 226corresponding to a respective filter 222 in the second plurality ofassessment filters 220-1 includes a prompt for the subject to indicatewhether they have discussed the risk factor underlying the respectivefilter in the second plurality of assessment filters that was fired witha health care practitioner (e.g., a licensed medical practitioner),e.g., and the health care practitioner indicated that the subject shouldtake a statin pharmaceutical composition in view of the underlying riskfactor. Accordingly, the algorithm obtains acknowledgement from thesubject when the subject indicates that they have discussed the riskfactor underlying the respective filter in the second plurality ofassessment filters that was fired with a health care provider. Forexample, message 702 in FIG. 7 illustrates a warning that is generic toany fired filter of the second type. In some embodiments, the warning isspecific to a particular filter (e.g., filter warning 656 in FIG. 6D),e.g., communicating to the user why the respective filter was fired.

In some embodiments, an acknowledgment from the user is verified by thehealth care practitioner (e.g., the method requires verification inorder for authorization of the provision of the statin pharmaceuticalcomposition), e.g., in order to verify an accuracy of the informationset obtained. In some embodiments, e.g., when the acknowledgment isverified by the heath care practitioner, the subject is deemed a trustedsubject, such that verification of future results is not required.

In some embodiments, the algorithm obtains acknowledgment from thesubject for any warning 226 issued to the subject by any filter 222 inthe second plurality of assessment filters. If a filter 216 in the firstplurality of assessment filters fires, the subject is denied provisionof the over-the-counter statin pharmaceutical composition.

Blocks 4156 through 4174. Referring to block 4156 of FIG. 4L, thealgorithm proceeds to a fulfillment process when no filter 216 in thefirst plurality of assessment filters 214-1 has been fired and thesubject has acknowledged each warning 226 associated with each filter222 in the second plurality of assessment filters 220-1 that was fired.In some embodiments, the fulfillment process includes storing anindication in a user profile 234 of an initial order date and/or adestination for the statin pharmaceutical composition. The initial orderdate is utilized, for example, to verify at least a refill status of aprovision of the statin pharmaceutical composition. The initial orderdate is also utilized, for example, to verify at least an elapsed periodof time between an initial order and a future re-order (e.g., aprovision of a re-assessment). Such verification is required in order toensure that certain tests (e.g., blood pressure tests) are takenregularly.

The fulfillment process further includes communicating anover-the-counter drug facts label 230 for the statin pharmaceuticalcomposition to the subject. In some embodiments, the drug facts label230 is communicated to the subject in real-time, e.g., within the sameuser interface as used for the qualification assessment process.

In some embodiments, the over-the-counter drug facts label 230 specifieswhat the statin pharmaceutical composition is for (e.g., to lowercholesterol, to treat heart disease, etc.) and any risks associated withtaking the statin pharmaceutical composition (e.g., drug-druginteractions, pharmacokinetic interactions, adverse reactions, etc.).For instance, in some embodiments, upon confirmation from the subjectthat the over the counter drug facts label 230 has been received andread, the subject is authorized for provision of a dosage of from 1 mgto 80 mg of statin pharmaceutical composition no more than once per day.In some embodiments, the subject is authorized for a provision of adosage of from 2.5 mg to 15 mg of statin (e.g., rosuvastatin) no morethan once per day (block 4160). In some embodiments, the subject isauthorized for a provision of a dosage of 5 mg of statin (e.g.,rosuvastatin) no more than once per day (block 4162). In someembodiments, the subject is authorized for a provision of a dosage offrom 20 mg to 40 mg of statin (e.g., fluvastatin) no more than once perday (block 4164). In some embodiments, the subject is authorized for aprovision of a dosage of from 10 mg to 40 mg of statin (e.g.,atorvastatin) no more than once per day (block 4166). In someembodiments, the subject is authorized for a provision of a dosage offrom 1 mg to 4 mg of statin (e.g., pitavastatin) no more than once perday (block 4168). In some embodiments, the subject is authorized for aprovision of a dosage of from 10 mg to 40 mg of statin (e.g.,lovastatin) no more than once per day (block 4170). In some embodiments,the subject is authorized for a provision of a dosage of from 10 mg to40 mg of statin (e.g., pravastatin) no more than once per day (block4172). In some embodiments, the subject is authorized for a provision ofa dosage of from 5 mg to 20 mg of statin (e.g., simvastatin) no morethan once per day (block 4174).

In some embodiments, the fulfillment process further includesauthorizing provision of the statin pharmaceutical composition to thesubject. The authorization occurs upon confirmation from the subjectthat the over-the-counter drug facts label 230 has been received andread by the subject. In some embodiments, this authorization includes adestination associated with the subject. In some embodiments, thedestination associated with the subject is stored in the user profile234. In some embodiments, the destination associated with the subject isa physical address including a street address, a Post Office box, apharmacy associated with the subject, a health care provider associatedwith the subject, and/or one or more coordinates (e.g., longitude,latitude, elevation). In some embodiments, the provision of the statinpharmaceutical composition to the subject includes shipping the statinpharmaceutical composition to the physical address associated with thesubject. In some embodiments, the provision of the statin pharmaceuticalcomposition to the subject includes shipping the statin pharmaceuticalcomposition to a pharmacy associated and/or a location associated with ahealth care provider of the subject and/or an office of a medicalpractitioner associated with the subject.

Referring to block 4176 of FIG. 4M, in some embodiments the methodincludes administering the statin pharmaceutical composition to thesubject after authorization of the provision of the statinpharmaceutical composition. The administration will typically beperformed by the subject themselves, just as it would be if the statinwas provided by prescription.

FIG. 5 illustrates method 5000 for re-qualifying (5002) a human subjectfor an over-the-counter provision of a statin pharmaceutical compositionfor lowering cholesterol, e.g., thereby, treating and/or preventingheart disease, using a computer system such as a statin pharmaceuticalcomposition OTC dispensing device 250. As illustrated in FIG. 2, thestatin pharmaceutical composition OTC dispensing device (e.g., device250) includes one or more processors (e.g., processor 274) and a memory(e.g., memory 192 and/or 290). The memory stores non-transitoryinstructions that, when executed by the one or more processors, performa method.

Method 5000 involves to collecting relevant biographical and medicalinformation about the subject, applying the collected information to analgorithm that applies the information against one or more filters of afirst type and one or more filters of a second type, and providingaccess to a statin pharmaceutical composition when each of the filtersis satisfied. The one or more filters of the first type terminate theprocess without re-qualifying the patient for access to anover-the-counter statin pharmaceutical agent when fired. The one or morefilters of the second type trigger transmission of a warning to thesubject when fired. The subject must confirm any transmitted warnings,which optionally include confirmation that certain conditions precedenthave been met (such as having a discussion with a medical professionaland receiving advice that the statin pharmaceutical composition is safeto take), before the subject is qualified to receive a reorder provisionof the statin pharmaceutical agent.

In some embodiments the statin pharmaceutical composition includesrosuvastatin (CRESTOR®) as an active ingredient. In some embodiments,the statin pharmaceutical composition includes an active ingredientselected from the group consisting of atorvastatin (LIPITOR®),fluvastatin (LESCOL®, LESCOL XL®), lovastatin (ALTOPREV®), pitavastatin(LIVALO®), pravastatin (PRAVACHOL®), and simvastatin (ZOCORφ). Thesestatin pharmaceutical compositions are described in Lee et al., 2007,“Comparison of Efficacy and Tolerability of Pitavastatin andAtorvastatin: an 8-Week, Multicenter, Randomized, Open-Label,Dose-Titration Study in Korean Patients with Hypercholesterolemia,” ClinTher. 2007; 29:2365-73; Bradford et al., 1990, “Expanded clinicalevaluation of lovastatin (EXCEL) study design and patientcharacteristics of a double blind, placebo controlled study in patientswith moderate hypercholesterolemia.American Journal of Cardiology 66: p.44B-55B; Serruys et al., 2002, “Fluvastatin for Prevention of CardiacEvents Following Successful First Percutaneous Coronary Intervention: ARandomized Controlled Trial.,” JAMA 287: p. 3215-3222; Sacks et al.1996, “The effect of pravastatin on coronary events after myocardialinfarction in patients with average cholesterol levels. Cholesterol andRecurrent Events Trial investigators,” New England Journal of Medicine,1996. 335(14): p. 001-9; Anonymous, 2002 “Heart Protection StudyCollaborative Group, MRC/BHF Heart Protection Study of cholesterollowering with simvastatin in 20,536 high-risk individuals: a randomisedplacebo-controlled trial,” Lancet 360: p. 7-22; Jones et al., 2003,“Comparison of the efficacy and safety of rosuvastatin versusatorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial),” Am J Cardiol. 92 (2): 152-60 each of which is hereby incorporated byreference. In some embodiments, the statin pharmaceutical compositioncomprises a statin and another lipid-lowering drug, such asAtorvastatin/Ezetimibe (LIPTRUZET®), Lovastatin+Niacin (ADVICOR®),Simvastatin/Ezetimibe (VYTORIN®), or Simvastatin/Niacin-ER (SIMCOR®).Further information regarding possible statin pharmaceuticalcompositions is provided above, e.g. ,with respect to method 4000, andis not repeated here for brevity.

Blocks 5000 through 5006. Referring to block 5002 of FIG. 5A, a goal ofthe present disclosure is to re-qualify subjects (e.g., a re-fulfillmentprocess) for provision of an over-the-counter statin pharmaceuticalcomposition to lower cholesterol, e.g., thereby, treating and/orpreventing heart disease, using a computer system such as a statinpharmaceutical composition OTC dispensing device 250. As illustrated inFIG. 2, the statin pharmaceutical composition OTC dispensing device(e.g., device 250) includes one or more processors (e.g., processor 274)and a memory (e.g., memory 192 and/or 290). The memory storesnon-transitory instructions that, when executed by the one or moreprocessors, perform a method (e.g., method 5000 of FIG. 5). In someembodiments, the present disclosure provides a method for qualifying asubject for a re-order (e.g., a re-assessment) of a provision of astatin pharmaceutical composition. In some embodiments, thequalification for a re-order of the statin pharmaceutical compositionfollows an initial qualification (e.g., an assessment) of the subject,as described herein. In some embodiments, the qualification for a refillof the statin pharmaceutical composition follows issuance of aprescription to the subject for the statin pharmaceutical composition.For example, in some embodiments, a subject who is new to thequalification process is asked whether they previously received aprescription for the statin pharmaceutical composition. Accordingly, ifthe subject indicates that they have not previously received aprescription, the subject is directed to an initial qualification method(e.g., method 4000 of FIG. 4) and, if the subject indicates that theyhave previously received a prescription, the subject is directed to there-fill qualification method, e.g., as described below.

In some embodiments, a re-fulfillment procedure is performed (e.g.,re-qualifying a human subject for an over-the-counter provision of astatin pharmaceutical composition). The re-fulfillment procedure isresponsive to receiving a re-order request from the subject for thestatin pharmaceutical composition. In some embodiments, a prompt toinitiate the re-fulfillment procedure is sent to a user device 102associated with the subject after a predetermined amount of timeassociated with a duration of dosages previously delivered to thesubject (e.g., the user is reminded to fulfill their order of the statinpharmaceutical composition just before, or just after, the user isscheduled to run out of a previously delivered provision.

In some embodiments, the statin pharmaceutical composition includes anactive ingredient of atorvastatin, fluvastatin, lovastatin,pitavastatin, pravastatin, rosuvastatin, or simvastatin. In someembodiments, the lowering of cholesterol is to treat and/or preventheart disease.

Referring to blocks 5008 and 5010 of FIG. 5A, in some embodiments there-fulfillment procedure includes providing a re-assessment survey forobtaining an information set from the subject (e.g., a secondinformation set). This information set is derived from correspondingre-assessment survey questions (e.g., the device 250 transmits one ormore re-assessment survey questions to the user, prompting a response,and then receives a response (e.g., a portion of the information set) tothe one or more re-assessment survey questions back from the subject).In some embodiments, the information set includes some or all of thecharacteristics listed in Table 5. For example, in some embodiments, theinformation set includes 1, 2, 3, 4, 5, 6, 7, or all 8 of thecharacteristic listed in Table 5. In one embodiment, the information setincludes at least characteristics 1-6 as provided in Table 5. In oneembodiment, the information set includes at least characteristics 2-6 asprovided in Table 5. In one embodiments, the information set alsoincludes the LCL cholesterol level of the subject. For example, in someembodiments, the information set includes at least characteristics 1-6and 8, as provided in Table 5. Similarly, in some embodiments, theinformation set includes at least characteristics 2-6 and 8, as providedin Table 5. In some embodiments, the information set also includes akidney function status of the subject. For example, in some embodiments,the information set includes at least characteristics 1-7, as providedin Table 5. Similarly, in some embodiments, the information set includesat least characteristics 2-7, as provided in Table 5. Similarly, in someembodiments, the information set includes at least characteristics 2-8,as provided in Table 5.

It will be appreciated that the survey questions 208, 212 and filters216, 222 (e.g., second plurality of re-assessment filters 216-2 andsecond plurality of re-assessment filters 222-2) applied to theinformation set thereof may vary depending upon the statinpharmaceutical composition being distributed. This varying is due todifferences in the contraindication profiles of the various the statinpharmaceutical compositions, e.g., due to different drug-druginteractions, routes of drug clearance, etc. of the different the statinpharmaceutical compositions. For example, co-administration of warfarinwith a single oral dose of atorvastatin had no significant effect on thepharmacokinetics of atorvastatin. As such, in some embodiments, anassessment survey, or similarly a re-assessment survey, qualifying asubject for an OTC provision of simvastatin may ask whether the subjectconsumes warfarin, while a similar survey qualifying a subject for OTCuse of rosuvastatin may not.

Referring to block 5010, and as further informed by the example workflowillustrated in FIG. 9, in some embodiments, the information set includeswhether the subject has had a documented cardiac event since receivingtheir last provision of the statin pharmaceutical composition (e.g.,responsive to a re-assessment survey question that is associated withand/or applied to (908) a cardiac event filter 216-12 in a firstplurality of re-assessment filters 214-2), when the subject isfemale—whether the subject is pregnant or breastfeeding (e.g.,responsive to a re-assessment survey question that is associated withand/or applied to (920) a pregnancy filter 216-14 in a first pluralityof re-assessment filters 214-2), whether the subject is taking one ormore compositions that interact with the statin pharmaceuticalcomposition (e.g., responsive to a re-assessment survey question that isassociated with and/or applied to either or both (922 and/or 936) asevere drug interaction filter 216-15 in a first plurality ofre-assessment filters 214-2 and/or a moderate drug interaction filter222-5 in a second plurality of re-assessment filters 220-2), whether thesubject has experienced liver problems since receiving their lastprovision of the statin pharmaceutical composition (e.g., responsive toa re-assessment survey question that is associated with and/or appliedto (924) a liver condition filter 216-16 in a first plurality ofre-assessment filters 214-2), whether the subject has experienced amuscle irregularity since receiving their last provision of the statinpharmaceutical composition (e.g., responsive to a re-assessment surveyquestion that is associated with and/or applied to (926) a muscleirregularity filter 216-17 in a first plurality of re-assessment filters214-2), and an alcohol consumption status of the subject since receivingtheir last provision of the statin pharmaceutical composition (e.g.,responsive to a re-assessment survey question that is associated withand/or applied to (934) an alcohol consumption filter 222-4 in a secondplurality of re-assessment filters 220-2).

In some embodiments, the re-assessment survey includes questions thatelicit responses providing some or all of the characteristics listed inTable 5. In some embodiments, the re-assessment survey includesquestions corresponding to the information set required for the methodsdescribed herein. In other embodiments, the reassessment survey includesquestions corresponding to only a subset of the information set requiredfor the methods described herein. In such embodiments, one or moreportions of the information set required for the methods describedherein are acquired through other means (e.g., uponregistration/subscription for a service associated with qualifying thesubject for over-the-counter medication, from a healthcare provider,from a prior survey, from a database associated with a pharmacy, from anelectronic health record associated with the subject, from the subjectprofile data store 232, etc.) For example, in some embodiments, thesubject provides a personal medical identification associated with aninsurer, a hospital, or other healthcare provider and information aboutthe subject required for the methods described herein, e.g., one or moresurvey results, is acquired from a preexisting database associated withthe personal medical identification (e.g., a recent LDL cholesterollevel measurement determined for the subject).

TABLE 5 Example Medical Information Elicited from the Re-assessmentInformation Set Result Example Characteristics 1 whether the subject hashad a documented cardiac event since receiving their last provision ofthe statin pharmaceutical composition 2 when the subject isfemale-whether the subject is pregnant or breastfeeding 3 whether thesubject is taking one or more compositions that interact with the statinpharmaceutical composition 4 whether the subject has experienced liverproblems since receiving their last provision of the statinpharmaceutical composition 5 whether the subject has experienced muscleirregularity since receiving their last provision of the statinpharmaceutical composition 6 an alcohol consumption status of thesubject since receiving their last provision of the statinpharmaceutical composition 7 whether the subject has developed kidneyproblems or experienced worsening of a previous kidney problem sincereceiving their last provision of the statin pharmaceutical composition8 a LDL cholesterol level of the subject

It is contemplated that, in some embodiments, any one or more of thesurvey questions provided in Table 5 will not be elicited by there-assessment survey (e.g., will not be used for the re-assessmentand/or will be obtained by other means). For example, in someembodiments, a characteristic associated with a particular surveyquestion will be informative when qualifying a subject for oneparticular statin but not for another statin. For instance, are-assessment survey question is queried for simvastatin qualifyingre-assessment surveys but not for rosuvastatin qualifying re-assessmentsurveys (e.g., the assessment survey question is not relevant forrosuvastatin). The skilled artisan will recognize that different statinpharmaceutical compositions carry different risk and drug interactionprofiles. Accordingly, survey information required for qualifying asubject for access to one statin pharmaceutical composition with a knownadverse drug interaction may not be necessary for qualifying the samesubject for access to a second statin pharmaceutical composition.

Accordingly, it is contemplated that the characteristics elicited by there-assessment survey questions include any sub-set of the informationset provided in Table 5. For brevity, all possible combinations of thecharacteristics provided in Table 5 are not specifically delineatedhere. However, the skilled artisan will easily be able to envision anyparticular subset of survey questions designed to elicit responses toany subset of characteristics provided in Table 5. Likewise, the skilledartisan may know of other survey questions, not provided in Table 5,that may be combined with any subset of the survey questions provided inTable 5 to form the re-assessment survey questions used in the methodsdescribed herein.

In some embodiments, the assessment survey and/or the re-assessmentsurvey is conducted by transmitting a plurality of respective questionsto the subject, e.g., some or all of the respective survey questions,and receiving answers to the plurality of respective survey questionsbefore applying any of the answers to respective filters. For example,with reference to the workflow in FIG. 9, in some embodiments, thedevice transmits questions relating to all of the re-assessment filtersof the first plurality of re-assessment filters, all of there-assessment filters of the second plurality of re-assessment filters,or all of the re-assessment filters in the workflow (e.g., as a virtualre-assessment survey where all of the questions are displayed in asingle user interface, or as a series of questions displayed inconsecutive user interfaces). After receiving answers to all of there-assessment survey questions, the device then applies an algorithm torun assessment information set against the re-assessment filters (e.g.,sequentially or concurrently) to determine whether the subject isre-qualified to receive a provision of the statin pharmaceuticalcomposition. In alternative embodiments, the device transmits questionsrelating to a subset of re-assessment filters of the first categoryclass, e.g., for which it could not obtain answers to the questions froman electronic database associated with the subject such as electronichealth record of the subject, and/or relating to a subset ofre-assessment filters of the second category class, e.g., that it couldnot obtain answers to the questions from an electronic databaseassociated with the subject (e.g., as a virtual re-assessment surveywhere such unanswered questions are displayed in a single userinterface, or as a series of questions displayed in consecutive userinterfaces). After receiving answers to all of the survey questions, thedevice then applies the answers to all of the filters (e.g.,sequentially or concurrently) to determine whether the subject isre-qualified to receive provision of the statin pharmaceuticalcomposition.

In some embodiments, the assessment survey and/or the re-assessmentsurvey is conducted in a serial fashion, e.g., by transmitting a firstquestion or a first group of survey questions (e.g., associated with asingle respective filter) to the subject, receiving an answer to thesingle survey question or small group of survey questions, and applyingan algorithm by running the answer or answers through a filter, prior totransmitting a second question or second group of questions to thesubject. For example, with reference to the workflow in FIG. 9, in someembodiments the device transmits a first re-assessment question to thesubject, relating to contraindicated drugs. After receiving the answerto the survey question, the device applies the algorithm to the answerby running (922) the answer through a severe drug interaction filtercardiac event filter. If the severe drug interaction filter is fired,the device terminates (909) the process, and optionally provides theuser with a message relating to why they are being denied a provision ofthe statin pharmaceutical composition, a suggestion for following-upwith a medical professional, and/or a suggestion to make a lifestylechange. In other embodiments, the assessment survey and/or thereassessment survey is completed prior to applying any of the answers tothe corresponding algorithm.

In some embodiments, one or more survey questions are not transmitted toa respective subject in accordance with a result to a previous surveyquestion. For instance, in some embodiments the pregnancy filter isbypassed because the subject is male (e.g., as shown in FIG. 9B) and,consequently, one or more re-assessment survey questions related topregnancy are bypassed (e.g., not transmitted to the user).

As described in detail below, the methods disclosed herein include stepsof applying information collected about a subject to a plurality offilters designed to identify contraindications—which render the subjectunsuitable for treatment with the statin pharmaceutical compositiongenerally or at least in the self-care environment (i.e., withoutphysician supervision)—and risk factors—which render administration ofthe statin pharmaceutical composition unnecessarily risky withoutfurther physician consultation. The contraindication and risk factorsdescribed herein are non-exhaustive, as the skilled artisan will know ofother possible contraindications or risk factors for a particular statinpharmaceutical composition. Moreover, as medical research progresses,new contraindications or risk factors may be discovered. Or, similarly,the classification of existing contraindications or risk factors maychange with additional medical research or consideration. For example, afactor considered to be a contraindication may be reclassified as a riskfactor, over time, or vice-a-versa.

Further, a contraindication for one statin pharmaceutical compositionmay only be a risk factor, or neither, for a different statinpharmaceutical composition, for example, based on different mechanisms,interaction, pharmacokinetic, and/or pharmacodynamics properties of therespective active ingredients. Similarly, a factor that is acontraindication or risk factor for a particular statin pharmaceuticalcomposition when administered at one dose, e.g., a high, moderate, orlow dose, may be classified differently when administered at a differentdose. For example, a contraindication for a statin pharmaceuticalcomposition administered at a high dose may only be a risk factor, orneither, when administered at a low dose. This is particularly true whenthe risk factor, e.g., a drug interaction, changes the bioavailabilityof the active ingredient by a certain factor, such that thebioavailability following high dose administration, but not low doseadministration, would increase beyond a safe threshold.

Referring to blocks 5012 and 5014 of FIG. 5A, the method includesapplying an algorithm to the information set obtained through, at leastin part, the re-assessment survey. The algorithm runs all or a portionof the information set against a first plurality of re-assessmentfilters 214-2. When a respective re-assessment filter in the firstplurality of reassessment filters 214-2 is fired (e.g., when are-assessment survey result indicates that a triggering condition 218has been met), the subject is deemed not qualified for the statinpharmaceutical composition and the method is terminated withoutauthorizing provision of the statin blocker pharmaceutical composition.

Referring to blocks 5016 through 5046 of FIGS. 5A and 5C, examplere-assessment filters in the first plurality of re-assessment filtersand example triggering conditions that cause the corresponding filtersto fire are described below.

TABLE 6 Example Re-Assessment Filters of the First Plurality ofRe-Assessment Filters Filter Type 1c a cardiac event filter 2c acholesterol status filter 3c a pregnancy filter 4c a severe druginteraction filter 5c a liver condition filter 6c a muscle irregularityfilter

In some embodiments, the first plurality of re-assessment filtersincludes some or all of the filters listed in Table 6. For example, insome embodiments, the first plurality of re-assessment filters includes2, 3, 4, 5, or all 6 of the filters listed in Table 6. In someembodiments, the first plurality of re-assessment filters includes atleast filters 1 c, 3 c, 4 c, and 6 c. In some embodiments, the firstplurality of re-assessment filters includes at least filters 1 c-4 c and6 c. In some embodiments, the first plurality of re-assessment filtersincludes at least filters 1 c and 3 c-6 c. In some embodiments, thefirst plurality of re-assessment filters includes at least filters 1 c-6c.

Accordingly, it is contemplated that in some embodiments the firstplurality of re-assessment filters includes any sub-set of filtersprovided in Table 6. Likewise, in some embodiments the skilled artisanmay know of other filters, not provided in Table 6, which may becombined with any subset of the filters provided in Table 6 to form thefirst plurality of re-assessment filters and corresponding informationset used in the methods described herein. For brevity, all possiblecombinations of the re-assessment filters provided in Table 6 are notspecifically delineated here.

It is contemplated that, in some embodiments, any one or more of there-assessment filters provided in Table 6 will not be included in thefirst plurality of re-assessment filters 214-2. For example, in someembodiments, a characteristic associated with a particular survey resultwill be informative when qualifying a subject for one particular statinpharmaceutical composition but not for another statin pharmaceuticalcomposition. In some embodiments, one or more of the filters provided inTable 6 is implemented as a second type filter (e.g., included in asecond plurality of re-assessment filters), as described below, whichgenerates a warning to the user and/or requires the user confirm theyhave discussed an underlying risk triggering the filter with a medicalprofessional, e.g., instead of automatically terminating the processwithout authorizing provision of the statin pharmaceutical composition.For example, in some cases, the decision to implement one of the filterslisted in Table 6 as a second type filter will be based on aconsideration specific to a particular statin compound and/or dosage ofthe statin compound. Similarly, in other cases, the decision toimplement one of the filters listed in Table 6 as a second type filterwill be based on a change in health and/or regulatory guidelines.

In some embodiments, the device is configured to conditionally bypassone or more of the filters in the first plurality of re-assessmentfilters. For example, as illustrated in example implementation 900, whenthe device determines the subject is a male (e.g., as illustrated instep 918 in FIG. 9B) the pregnancy filter applied at step 920 isbypassed because it is not possible for the subject to become pregnant.

Cardiac Event Filter

Referring to block 5016 and 5018 of FIG. 5A, in some embodiments thefirst plurality of re-assessment filters 214-2 includes a cardiac eventfilter 216-12. In some embodiments, the cardiac event filter 216-12 isas described above in relation to the cardiac event filter 216-4. Insome embodiments, the cardiac event filter is configured to be fired atleast when the information set indicates that the subject has had adocumented cardiac event since receiving their last provision of thestatin pharmaceutical composition. In some embodiments, the cardiacevent filter is fired when the information set indicates the subject hada heart attack, had a stroke, has undergone a heart procedure, or hasdeveloped peripheral artery disease since receiving their last provisionof the statin pharmaceutical composition. Examples of heart proceduresthat, in some embodiments, may fire the cardiac event filter includeopen-heart surgery, coronary artery bypass surgery, heart valvereplacement and/or repair, surgery to treat heart arrhythmia, aneurysmrepair surgery, coronary revascularization surgery, carotidendarterectomy, heart transplant, and the like.

In some embodiments, e.g., when implemented as a first type of filter,when the cardiac event filter is fired, the subject is not permitted toobtain provision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter (e.g., the method is terminated withoutauthorizing provision of the statin pharmaceutical composition to thesubject). In some embodiments, e.g., when implemented as a second typeof filter, when the cardiac event filter is fired, the subject is issueda warning associated with the filter, but is eligible to obtainprovision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter upon satisfying the acknowledgementcriteria associated with the warning (e.g., by confirming that they havediscussed the risk factor with a medical professional and/or the medicalprofessional has advised that the subject should take a statinpharmaceutical agent despite the risk factor).

Cholesterol Status Filter

Referring to blocks 5020 through 5026 of FIG. 5B, in some embodimentsthe first plurality of re-assessment filters 214-2 includes acholesterol status filter 216-13. In some embodiments, the cholesterolstatus filter 216-13 is configured to be fired at least when theinformation set indicates that a cholesterol level of the subject hasnot been reduced by at least a threshold amount since receiving theirfirst dosage of the statin pharmaceutical agent. In some embodiments,the cholesterol level is an LDL cholesterol level. In some embodiments,the threshold amount is 10%. In other embodiments, the threshold amountis about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, ormore. In some embodiments, the threshold amount is variable, dependingupon the starting cholesterol level of the subject. For instance, insome embodiments, the threshold amount of cholesterol reduction is sethigher for subjects starting with a significantly elevated cholesterollevel and lower for subjects starting with a mildly elevated cholesterollevel. Generally, the subject is prompted to input their lastcholesterol level (e.g., last LDL cholesterol level) and the system willcompare that level to a previous cholesterol level, e.g., stored insubject profile data store 232.

In some embodiments, the cholesterol status filter is bypassed undercertain conditions. For example, as illustrated in exampleimplementation 900, when the device determines that a reduction in thesubject's cholesterol level was previously verified (910), thecholesterol status filter implemented at step 912 is bypassed.Similarly, as also illustrated in example implementation 900, when thedevice determines that the subject has not retested their cholesterollevels since receiving their first provision of the statinpharmaceutical agent, the cholesterol status filter implemented at step912 is bypassed. However, in some embodiments, if the device determinesthat the subject has not retested their cholesterol levels sincereceiving their first provision of the statin pharmaceutical agent, thedevice will prompt the subject to re-test their cholesterol level,particularly when a significant period of time has passed sincereceiving their first provision of the statin pharmaceutical agent.

In some embodiments, e.g., when implemented as a first type of filter,when the cholesterol status filter is fired, the subject is notpermitted to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the cholesterol status filter is fired,the subject is issued a warning associated with the filter, but iseligible to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

Pregnancy Filter

Referring to block 5028 of FIG. 5B, in some embodiments the firstplurality of re-assessment filters 214-2 includes a pregnancy filter216-14. In some embodiments, the pregnancy filter 214-14 is as describedabove in relation to the pregnancy assessment filter 216-2. In someembodiments, the pregnancy filter 216-14 is configured to be fired atleast when the information set indicates that the subject is pregnant orthe subject is breastfeeding. In some embodiments, the pregnancy filter216-14 is also configured to be fired when the information set indicatesthat the subject is planning on becoming pregnant. In some embodiments,the pregnancy filter is only applied when the information set indicatesthat the subject is female, e.g., the pregnancy filter is bypassed whenthe subject is male (e.g., as illustrated at steps 918-922 of workflow900 in FIG. 9B).

In some embodiments, e.g., when implemented as a first type of filter,when the pregnancy filter is fired, the subject is not permitted toobtain provision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter (e.g., the method is terminated withoutauthorizing provision of the statin pharmaceutical composition to thesubject). In some embodiments, e.g., when implemented as a second typeof filter, when the pregnancy filter is fired, the subject is issued awarning associated with the filter, but is eligible to obtain provisionof the statin pharmaceutical composition pharmaceutical compositionover-the-counter upon satisfying the acknowledgement criteria associatedwith the warning (e.g., by confirming that they have discussed the riskfactor with a medical professional and/or the medical professional hasadvised that the subject should take a statin pharmaceutical agentdespite the risk factor).

Severe Drug Interaction Filter

Referring to block 5030 through 5042 of FIGS. 5B and 5C, in someembodiments, the first plurality of re-assessment filters includes asevere drug interaction filter 216-15. In some embodiments, the severedrug interaction filter 216-15 is as described above in relation to thesevere drug interaction filter 226-3. In some embodiments, the severedrug interaction filter 216-15 is configured to be fired at least whenthe information set indicates that the subject is taking (e.g., hasstarted taking) one or more compositions that interact with the statinpharmaceutical composition e.g., a pharmacokinetic interaction and/or apharmacodynamic interaction, and is contraindicated forco-administration with the statin pharmaceutical composition.Non-limiting examples of drugs that may be contraindicated forco-administration with a statin pharmaceutical composition, e.g., basedon the particular statin, include cyclosporine, an anti-viral proteaseinhibitor, warfarin, a strong CYP3A4 inhibitor, and another cholesterollowering medication.

As previously described, these interactions can be pharmacodynamicdrug-drug interactions or pharmacokinetic drug-drug interactions.Typically, the interactions (e.g., triggering conditions 224) that arecapable of firing the severe drug interaction filter 216-15 are the sameas the interactions that are capable of firing the severe druginteraction filter 216-3 assuming that statin pharmaceutical compositionis the same between the fulfillment process and the re-fulfillmentprocess.

In some embodiments, e.g., when implemented as a first type of filter,when the severe drug interaction filter is fired, the subject is notpermitted to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing re-provision of the statin pharmaceuticalcomposition to the subject).

In some embodiments, e.g., when the statin pharmaceutical compositionincludes atorvastatin, fluvastatin, lovastatin, or pitavastatin as anactive ingredient, the severe drug interaction filter is configured tobe fired when the information set indicates that the subject is takingcyclosporine.

In some embodiments, e.g., when the statin pharmaceutical compositionincludes fluvastatin, lovastatin, or pravastatin as an activeingredient, the severe drug interaction filter is configured to be firedwhen the information set indicates the subject is already taking acholesterol-lowering medication or a triglyceride-lowering medication.

In some embodiments, e.g., when the statin pharmaceutical compositionincludes lovastatin, pitavastatin, or simvastatin as an activeingredient, the severe drug interaction filter is configured to be firedwhen the information set indicates the subject is taking an anti-viralprotease inhibitor.

In some embodiments, e.g., when the statin pharmaceutical compositionincludes fluvastatin as an active ingredient, the severe druginteraction filter is configured to be fired when the informationindicates the subject is taking warfarin.

In some embodiments, e.g., when the statin pharmaceutical compositionincludes lovastatin or simvastatin as an active ingredient, the severedrug interaction filter is configured to be filed when the informationset indicates the subject is taking a strong CYP3A4 inhibitor.

In some embodiments, e.g., when the statin pharmaceutical compositionincludes rosuvastatin as an active ingredient, the severe druginteraction filter is configured to be fired when the information setindicates the subject is taking cyclosporine, a cholesterol-loweringmedication, a triglyceride-lowering medication, or warfarin.

As will be appreciated, compositions that are contraindicated, orrepresent a risk factor, for co-administration with a statinpharmaceutical composition vary from one statin pharmaceuticalcomposition to another statin pharmaceutical composition. The skilledartisan will know, for example, of one or more compositions thatinteract with one statin pharmaceutical composition but not another.Inclusion of a composition within the severe drug interaction filter isdependent upon the identity and/or the dosage of the statinpharmaceutical composition being authorized for a provision ofover-the-counter use.

As described further below, in some embodiments, use a drug thatinteracts with a statin pharmaceutical composition in a less severefashion, e.g., which is a risk factor rather than a contraindication, issufficient to trigger firing of a filter in the second filter categoryclass (e.g., a moderate drug interaction filter), rather than the severedrug interaction filter of the first plurality of re-assessment filters.For example, according to some embodiments, a particular composition isincluded in the severe drug interaction filter (e.g., as acontraindication) for a first statin pharmaceutical composition, butincluded in a filter in the second plurality of re-assessment filters(e.g., as a risk factor) for a second statin pharmaceutical composition.A person skilled in the art will know whether to include a certaincomposition within the severe drug interaction filter or as a separatefilter in the second plurality of re-assessment filters (e.g., amoderate drug interaction filter), based on the severity and risk of thedrug interaction with the particular identity and dosage of the statinbeing authorized for provision of over-the-counter use.

Liver Condition Filter

Referring to block 5044 of FIG. 5C, in some embodiments the firstplurality of re-assessment filters includes a liver condition filter216-16. In some embodiments, the liver condition filter 214-16 is asdescribed above in relation to the liver condition filter 216-11. Insome embodiments, the liver condition filter 216-16 is configured to befired at least when the information set indicates that the subject hasdeveloped or been newly diagnosed with a liver condition since receivingtheir last provision of the statin pharmaceutical composition. In someembodiments, a new liver condition is identified based on new symptomsprovided in the information set, e.g., inflammation of the liver,fibrosis, cirrhosis, end-stage liver disease (ESLD), cancer of theliver, and/or liver failure.

In some embodiments, e.g., when implemented as a first type of filter,when the liver condition filter is fired, the subject is not permittedto obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing re-provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the liver condition filter is fired,the subject is issued a warning associated with the filter, but iseligible to obtain re-provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

Muscle Irregularity Filter

Referring to block 5046 of FIG. 5C, in some embodiments the firstplurality of re-assessment filters includes a muscle irregularity filter216-16. In some embodiments, the muscle irregularly filter 216-17 isconfigured to be fired at least when the information set indicates thatthe subject has experienced unexplained muscle pain and/or weaknesssince receiving their last provision of the statin pharmaceuticalcomposition.

In some embodiments, e.g., when implemented as a first type of filter,when the muscle irregularity filter is fired, the subject is notpermitted to obtain provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing re-provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the muscle irregularity filter isfired, the subject is issued a warning associated with the filter, butis eligible to obtain re-provision of the statin pharmaceuticalcomposition pharmaceutical composition over-the-counter upon satisfyingthe acknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

Referring to block 5048 of FIG. 5D, in some embodiments the method alsoincludes using the algorithm to run all or a portion of the informationset against a second plurality of re-assessment filters 220-2. When arespective filter 222 in the second plurality of re-assessment filters220-2 is fired, the subject is provided with a warning corresponding tothe respective filter. In some embodiments, the warning is provided as anext step, e.g., prior to applying the information set to any subsequentfilters, after the corresponding filter is fired. For example, withrespect to FIGS. 9A and 9B, in some embodiments, the device wouldprovide the subject with a warning prior to proceeding to the proceedingfilter, e.g., requiring the subject confirm they have discussed thewarning with a health care provider and the healthcare provider stillrecommends taking a statin pharmaceutical composition. In someembodiments, the warning is provided after applying the information setto all subsequent filters. Further details on possible implementationsof these second type filters is described above with respect to theassessment workflow, and is not repeated here for brevity.

Referring to FIG. 5, example re-assessment filters 222 in the secondplurality of assessment filters 220 and example triggering conditions224 that cause the corresponding re-assessment filters to fire aredescribed.

TABLE 7 Example Second Plurality of Re-Assessment Filters FilterExemplary Criteria 1d an alcohol consumption filter 2d a moderate druginteraction filter 3d a kidney disorder filter

In some embodiments, the second plurality of re-assessment filters 220includes some or all of the filters 222 listed in Table 7. For example,in some embodiments, the second plurality of re-assessment filters 220includes 1, 2, or all 3 of the filters listed in Table 4. In someembodiment, the second plurality of assessment filters includes at leastfilter 1 d. In some embodiments, the second plurality of assessmentfilters includes at least filter 2 d. In some embodiments, the secondplurality of assessment filters includes at least filter 3 d. In someembodiments, the second plurality of assessment filters includes atleast filters 1 d and 2 d. In some embodiments, the second plurality ofassessment filters includes at least filters 1 d and 3 d. In someembodiments, the second plurality of assessment filters includes atleast filters 2 d and 3 d. In some embodiments, the second plurality ofassessment filters includes at least filters 1 d-3 d.

Accordingly, it is contemplated that in some embodiments the secondplurality of re-assessment filters includes any sub-set of filtersprovided in Table 7. Likewise, in some embodiments the skilled artisanmay know of other filters, not provided in Table 7, which may becombined with any subset of the filters provided in Table 7 to form thesecond plurality of re-assessment filters and corresponding informationset used in the methods described herein.

It is contemplated that, in some embodiments, any one or more of there-assessment filters provided in Table 7 will not be included in thesecond plurality of re-assessment filters. For example, in someembodiments, a characteristic associated with a particular survey resultwill be informative when qualifying a subject for one particular statinpharmaceutical composition but not for another statin pharmaceuticalcomposition. In some embodiments, one or more of the filters provided inTable 7 is implemented as a first type filter (e.g., included in a firstplurality of re-assessment filters), as described above, whichautomatically terminates the process without authorizing provision ofthe statin pharmaceutical composition when fired. For example, in somecases, the decision to implement one of the filters listed in Table 7 asa first type filter will be based on a consideration specific to aparticular statin compound and/or dosage of the statin compound.Similarly, in other cases, the decision to implement one of the filterslisted in Table 7 as a first type filter will be based on a change inhealth and/or regulatory guidelines.

Alcohol Consumption Filter

Referring to block 5050 of FIG. 5D, in some embodiments the secondplurality of re-assessment filters 220-2 includes an alcohol consumptionfilter 222-5 (e.g., filter 1 d in Table 7). In some embodiments, thealcohol consumption filter 222-5 is as described above in relation tothe alcohol consumption filter 222-1. The alcohol consumption filter isconfigured to be fired at least when the information set indicates thatthe alcohol consumption status of the subject fails to satisfy a ceilingalcohol consumption threshold. In some embodiments, the ceiling alcoholconsumption threshold is an average daily consumption. For instance, insome embodiments, the ceiling alcohol consumption threshold is anaverage daily consumption of no more than two alcoholic drinks. That is,in such embodiments, the alcohol consumption filter is configured to befired when the information set indicates the subject consumes three ormore alcoholic drinks per day. In other embodiments, the ceiling alcoholconsumption threshold is an average daily consumption of no more thanone alcoholic drink, no more than three alcoholic drinks, or no morethan four alcoholic drinks. In some embodiments, the alcohol consumptionfilter is also configured to be fired when the information set indicatesthe subject partakes in binge drinking more frequently than a thresholdfrequency, e.g., at least once a week, at least 2, 3, 4, 5, 6, or moretimes per month.

In some embodiments, e.g., when implemented as a first type of filter,when the alcohol consumption filter is fired, the subject is notpermitted to obtain re-provision of the statin pharmaceuticalcomposition pharmaceutical composition over-the-counter (e.g., themethod is terminated without authorizing provision of the statinpharmaceutical composition to the subject). In some embodiments, e.g.,when implemented as a second type of filter, when the alcoholconsumption filter is fired, the subject is issued a warning associatedwith the filter, but is eligible to obtain re-provision of the statinpharmaceutical composition pharmaceutical composition over-the-counterupon satisfying the acknowledgement criteria associated with the warning(e.g., by confirming that they have discussed the risk factor with amedical professional and/or the medical professional has advised thatthe subject should take a statin pharmaceutical agent despite the riskfactor).

Moderate Drug Interaction Filter

Referring to blocks 5050 through 5054 of FIG. 5D, in some embodimentsthe second plurality of re-assessment filters 220-2 includes a moderatedrug interaction filter 222-6 (e.g., filter 2 d in Table 7). In someembodiments, the moderate drug interaction filter 222-6 is as describedwith respect to the moderate drug interaction filter 222-3. The moderatedrug interaction filter is configured to be fired at least when theinformation set indicates that the subject is taking one or morecompositions that interacts with the statin pharmaceutical composition,e.g., a pharmacokinetic interaction and/or a pharmacodynamicinteraction, but is not necessarily contraindicated forco-administration with the statin pharmaceutical composition. Forexample, a composition associated with a warning for co-administrationwith the statin pharmaceutical composition. Non-limiting examples ofdrugs that may be associated with warnings when co-administered with astatin pharmaceutical composition, e.g., based on the particular statin,include colchicine and an anti-viral protease inhibitor.

In some embodiments, e.g., when implemented as a second type of filter,when the moderate drug interaction filter is fired, the subject isissued a warning associated with the filter, but is eligible to obtainre-provision of the statin pharmaceutical composition pharmaceuticalcomposition over-the-counter upon satisfying the acknowledgementcriteria associated with the warning (e.g., by confirming that they havediscussed the risk factor with a medical professional and/or the medicalprofessional has advised that the subject should take a statinpharmaceutical agent despite the risk factor).

As will be appreciated, compositions that are contraindicated, orrepresent a risk factor, for co-administration with a statinpharmaceutical composition vary from one statin pharmaceuticalcomposition to another statin pharmaceutical composition. The skilledartisan will know, for example, of one or more compositions thatinteract with one statin pharmaceutical composition but not another.Inclusion of a composition within the moderate drug interaction filteris dependent upon the identity and/or the dosage of the statinpharmaceutical composition being authorized for a provision ofover-the-counter use.

As described above, in some embodiments, use a drug that interacts witha statin pharmaceutical composition in a more severe fashion, e.g.,which is a contraindication, may trigger firing of a filter 216 in thefirst filter category class 214 (e.g., a severe drug interactionfilter), rather than the moderate drug interaction filter 222 of thesecond plurality of re-assessment filters 220. For example, according tosome embodiments, a particular composition is included in the severedrug interaction filter 216 (e.g., as a contraindication) for a firststatin pharmaceutical composition, but included in a filter in thesecond plurality of re-assessment filters (e.g., as a risk factor) for asecond statin pharmaceutical composition. A person skilled in the artwill know whether to include a certain composition within the severedrug interaction filter 216-3 or as a separate filter 222 in the secondplurality of re-assessment filters (e.g., a moderate drug interactionfilter), based on the severity and risk of the drug interaction with theparticular identity and dosage of the statin being authorized forprovision of over-the-counter use.

Kidney Disorder Filter

Referring to block 5056 of FIG. 5D, in some embodiments the secondplurality of assessment filters includes a kidney disorder filter (e.g.,filter 3 d in Table 7). For instance, in some embodiments when thestatin pharmaceutical composition includes rosuvastatin, atorvastatin,fluvastatin, and/or pitavastatin, the algorithm applies the kidneycondition filter to the information set. The kidney disorder filter isconfigured to be fired at least when the information set indicates thatthe subject has developed kidney problems (e.g., kidney disease) orexperienced worsening of a previous kidney problem since receiving theirlast provision of the statin pharmaceutical composition. In someembodiments, the kidney disorder filter is configured to be fired atleast when the information set indicates that the subject has been newlydiagnosed with kidney disease. In some embodiments, symptoms of a kidneyproblem capable of firing the kidney disorder filter include fatigue, afeeling of coldness, shortness of breath, a feeling of faintness,dizziness, weakness, a feeling of itchiness, and/or swelling of thehands and feet

In some embodiments, e.g., when implemented as a first type of filter,when the kidney disorder filter is fired, the subject is not permittedto obtain re-provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing re-provision of the statin pharmaceuticalcomposition to the subject). In some embodiments, e.g., when implementedas a second type of filter, when the kidney disorder filter is fired,the subject is issued a warning associated with the filter, but iseligible to obtain re-provision of the statin pharmaceutical compositionpharmaceutical composition over-the-counter upon satisfying theacknowledgement criteria associated with the warning (e.g., byconfirming that they have discussed the risk factor with a medicalprofessional and/or the medical professional has advised that thesubject should take a statin pharmaceutical agent despite the riskfactor).

Referring to block 5058 of FIG. 5D, in some embodiments the algorithmobtains acknowledgment from the subject for each warning issued to thesubject by any filter in the second plurality of re-assessment filters220-2. As described with respect to the warnings issued in conjunctionwith the second plurality of assessment filters 220-1, in someembodiments, the warning includes a prompt for the subject to indicatewhether they have discussed the risk factor underlying the respectivefilter in the second plurality of re-assessment filters 220-2 that wasfired with a health care practitioner (e.g., a licensed medicalpractitioner), e.g., and the health care practitioner indicated that thesubject should take a statin pharmaceutical composition in view of theunderlying risk factor. Accordingly, acknowledgement is obtained fromthe subject when the subject indicates that they have discussed the riskfactor underlying the respective filter in the second plurality ofre-assessment filters 220-2 that was fired with a health care provider.

Referring to block 5060 of FIG. 5E, in some embodiments algorithmproceeds with a re-fulfillment process when the re-fulfillment processis not already terminated by the firing of a filter in the firstplurality of re-assessment filters 214-2 (e.g., the pregnancy filter216-14). Moreover, in order for the re-fulfillment process to complete,the subject is required to acknowledge each warning associated with eachfilter 222 in the second plurality of re-assessment filters 220-2 thatwas fired.

Referring to block 5062 of FIG. 5E, in some embodiments when arespective filter in the first plurality of re-assessment filters 214-2or the second plurality of re-assessment filters 220-2 is fired, arecord associated with the firing of the respective filter is stored(e.g., memorializing an adverse event that is required to be reported toa regulatory agency). This record is stored in an adverse event module242 which includes records of filter firing events associated with aplurality of subjects (e.g., an aggregation of adverse events associatedwith the statin pharmaceutical composition across a population ofsubjects taking the statin pharmaceutical composition over-the-counter).In some embodiments, an indication of the adverse event is communicatedto a third party (e.g., a medical practitioner associated with thesubject, a health care provider of the subject, and/or amanufacturer/promoter of the statin pharmaceutical composition). In someembodiments, the indication is automatically stored in the adverse eventmodule 242 when submitted by a subject as part of the re-assessmentsurvey.

In some embodiments, an adverse event that is required to be reportedincludes an allergic reaction (e.g., a side effect and/or a druginteraction including a severe and/or a moderate drug interaction) ofany type or kind as described above. In some embodiments, an adverseevent that is required to be reported includes an anticipated and/orrecent change in pregnancy status of a respective subject. In someembodiments, an adverse event that is required to be reported includesan indication that a respective subject has had a documented cardiacevent. In some embodiments, an adverse event that is required to bereported includes an indication that a respective subject has developeda liver condition. In some embodiments, an adverse event that isrequired to be reported includes an indication that a respective subjecthas experienced unexplained muscle pain or weakness. Furthermore, insome embodiments an adverse event that is required to be reportedincludes an indication that a respective subject has developed a kidneyproblem or experienced a worsening of a previous kidney problem.

Referring to block 5062 of FIG. 5E, in some embodiments there-fulfillment process also includes storing an indication in the userprofile 234 of the subject of a re-order 238 for the statinpharmaceutical composition. The re-fulfillment process further includescommunicating an over-the-counter drug facts label 230 for the statinpharmaceutical composition to the subject. As previously described, thecommunication of the over-the-counter drug facts label 230 can occur ina variety of means. Upon confirmation from the subject that theover-the-counter drug facts label 230 has been received and read, themethod includes authorizing a re-order provision of the statinpharmaceutical composition to the subject. In some embodiments, thisre-order provision includes the destination of the subject.

Referring to block 5084 and 5088 of FIGS. 5F and 5G, in some embodimentsthe method (e.g., method 5000) is terminated without authorizingre-provision of the statin pharmaceutical composition to the subjectwhen less than a threshold period of time has passed since the subjectreceived their last provision of the statin pharmaceutical composition.In some embodiments, the subject's last provision of the statinpharmaceutical composition included daily dosages of the statinpharmaceutical composition for a predetermined number of days.Accordingly, the threshold period of time since receiving their lastprovision of the statin pharmaceutical composition, for terminating themethod, is a period of time greater than half the predetermined numberof days. In some embodiments, the method is terminated withoutauthorizing re-provision of the statin pharmaceutical composition to thesubject when the second information set indicates the subject has notyet retested their cholesterol following their first provision of thestatin pharmaceutical composition, and has ordered the statinpharmaceutical composition at least three times.

Referring to block 5090 of FIG. 5F, in some embodiments the methodincludes administering the statin pharmaceutical composition to thesubject after authorization of the re-provision of the statinpharmaceutical composition.

Example Implementations

Having described methods for qualifying (4000) and re-qualifying (5000)subjects to receive an over-the-counter statin pharmaceuticalcomposition above, example implementations for these processes aredescribed below. The example implementations below are not meant tolimit the scope of the disclosure, but rather to assist withunderstanding methods 4000 and 5000 described herein. In someembodiments, methods 4000 and 5000 include specific pieces of theexample implementation described below, without being limited to theentirety of the example implementation. For example, in someembodiments, methods 4000 and/or 5000 include a step of determining(e.g., 804) whether the subject has adequate privacy to continue withthe qualification process. Although described below as an iterative datacollection and analysis work flow, the method can also be implemented bycollecting some or all required information from the subject prior toapplying the relevant filters, as described above.

FIG. 8 illustrates an example method (800) (e.g., performed at anelectric device) for qualifying a subject for a provision of anover-the-counter statin pharmaceutical composition. In some embodiments,the method of FIG. 8 is utilized when the subject has not beenpreviously qualified for the medication (e.g., an assessment for themedication). In some embodiments, the method of FIG. 8 is utilized whenthe subject was previously qualified for the statin pharmaceuticalcomposition but a predetermined period of time elapsed since theprevious qualification occurred (e.g., the most recent qualification ofthe subject was greater than one year ago).

Referring to FIG. 8, the device prompts (802) the user to confirm thatthey know at least their blood pressure and cholesterol levels (e.g.,because in some embodiments the subject must know their blood pressureand their total cholesterol, including their HDL, values in order tocomplete the qualification process). If the subject indicates they donot know their blood pressure and/or cholesterol level, the processterminates (801) without authorizing provision of the statinpharmaceutical composition, and optionally transmits advice to the userto return later, e.g., once they know their blood pressure andcholesterol levels. If the subject indicates they know their bloodpressure and cholesterol levels, the process continues, with the deviceprompting (804) the subject to acknowledge a privacy notice. Since thepresent disclosure requires the subject to know and input sensitivemedical information (e.g., information only the subject and a medicalpractitioner have access to), privacy of this information is important.Once the subject has acknowledged they have the requisite privacy forcontinuing, the process continues.

The device prompts the subject to provide information their gender andthen applies (806) the answer received from the subject to a genderfilter. The process continues, with the device prompting the subject toprovide information regarding their age and then applies (808-1 and/or808-2) the answer received from the subject to an age filter (e.g., agefilter 216-1 of FIG. 3A and/or filter 1 a in Table 2). When the agefilter is fired (e.g., when the answer indicates the subject is femaleand of childbearing age or the subject is male and is younger than 20years of age or older than 75 years of age), the device terminates (803)the qualification process without authorizing provision of the stainpharmaceutical composition and, optionally, transmits advice to the useras to why they should not take the statin pharmaceutical composition.

When the subject is female and of age, the device proceeds with thequalification process, prompting the subject to indicate whether thesubject is pregnant or breastfeeding and then applies (810) the answerreceived from the subject to a pregnancy filter (e.g., pregnancy filter216-2 of FIG. 3A and/or filter 2 a in Table 2). When the pregnancyfilter is fired (e.g., when the answer indicates the subject ispregnant, breastfeeding, or, optionally, planning to become pregnant),the device terminates (803) the qualification process withoutauthorizing provision of the statin pharmaceutical agent and,optionally, transmits advice to the user as to why they should not takethe statin pharmaceutical composition.

When the pregnancy filter is not fired (e.g., when the subject is maleor the subject indicates a non-pregnant or non-breastfeeding status),the device proceeds with the qualification process, prompting (812) thesubject to indicate their race. When the answer indicates the subject isof South Asian descent, the device creates a record (813-1) indicatingthat the user has a risk enhancing factor.

The device then proceeds with the qualification process, prompting thesubject to indicate if they are taking a composition that interacts withthe statin pharmaceutical composition and then applies (814) the answerreceived from the subject to a severe drug interaction filter (e.g.,filter 216-3 of FIG. 3A and/or filter 3 a in Table 2). When the severedrug interaction filter is fired (e.g., when the answer indicates thesubject is taking a medication that has a severe interaction with thestatin pharmaceutical composition), the device terminates (803) thequalification process without authorizing provision of the statinpharmaceutical composition and, optionally, transmits advice to the useras to why they should not take statin pharmaceutical composition.

When the drug interaction assessment filter is not fired, the deviceproceeds with the qualification process, prompting the subject indicatewhether they have ever experienced a documented cardiac event and thenapplies (816) the answer received from the subject to a cardiac eventfilter (e.g., filter 216-4 of FIG. 3A and/or filter 4 a in Table 2).When the cardiac event filter is fired (e.g., when the subject indicatesa personal documented cardiac event), the device terminates (805) thequalification process without authorizing provision of the statinpharmaceutical composition and, optionally, transmits advice to the userto discuss taking a statin pharmaceutical composition with a medicalprofessional.

When the cardiac event filter is not fired, the device prompts (818) theuser to indicate whether there is a history of premature heart diseasein their family (e.g., collecting information relevant to a riskenhancing factor filter). If the answer to whether there is a history ofpremature cardiac disease in the user's family is yes, the devicecreates a record (813-2) indicating that the user has a risk enhancingfactor.

If the process has not yet been terminated, the device proceeds with thequalification process by evaluating whether the user is a male under athreshold age, e.g., 40, and if so follows bypass path B, which iscontinued in FIG. 8H. If the user is not a male under the threshold age,the device proceeds by prompting the subject to provide informationabout their total cholesterol level and then applies (824) the answerreceived from the subject to a total cholesterol filter (e.g., filter216-5 of FIG. 3A and/or filter 5 a in Table 2). When the totalcholesterol filter is fired (e.g., when the subject indicates a totalcholesterol level of less than 130 mg/dL or greater than 320 mg/dL), thedevice terminates (803) the qualification process without authorizingprovision of the statin pharmaceutical composition and, optionally,transmits advice to the user as to why they should not take statinpharmaceutical composition.

When the total cholesterol filter is not fired, the device proceeds withthe qualification process, prompting the subject to provide informationabout their LDL cholesterol level and then applies (826) the answer toan LDL cholesterol filter (e.g., filter 216-6 of FIG. 3A and/or filter 6a in Table 2). When the LDL cholesterol filter is fired (e.g., when thesubject indicates an LDL cholesterol level of less than 70 mg/dL or atleast 190 mg/dL), the device terminates (803 or 805) the qualificationprocess without authorizing provision of the statin pharmaceuticalcomposition and, optionally, transmits advice to the user as to why theyshould not take statin pharmaceutical composition and/or to discusstaking a statin pharmaceutical composition with a medical professional(e.g., where their LDL cholesterol level is at least 190 mg/dL). If thesubject's answer indicates their LDL cholesterol level is intermediatelyelevated (e.g., between 160 mg/dL and 190 mg/dL), the device creates arecord (813-3) indicating that the user has a risk enhancing factor.

When the LDL cholesterol filter is not fired, the device proceeds byprompting the subject to provide information about their HDL cholesterollevel and then applies (828) the answer to an HDL cholesterol filter(e.g., filter 216-7 of FIG. 3A and/or filter 7 a in Table 2). When theHDL cholesterol filter is fired (e.g., when the subject indicates an HDLcholesterol level of less than 20 mg/dL or at least 100 mg/dL), thedevice terminates (803) the qualification process without authorizingprovision of the statin pharmaceutical composition and, optionally,transmits advice to the user as to why they should not take statinpharmaceutical composition. If the subject's answer indicates their LDLcholesterol level is intermediately decreased (e.g., between 20 mg/dLand 40 mg/dL), the device creates a record (815-1) indicating that theuser has an indicator of metabolic disease.

When the HDL cholesterol filter is not fired, the device proceeds byprompting the subject to provide information about their triglyceridelevel and applies (830) the answer received from the subject to atriglyceride level filter (e.g., filter 216-8 of FIG. 3A and/or filter 8a in Table 2). When the triglyceride level filter is fired (e.g., whenthe subject indicates a triglyceride level of at least 500 mg/dL), thedevice terminates (805) the qualification process without authorizingprovision of the statin pharmaceutical composition and, optionally,transmits advice to the user as to why they should not take statinpharmaceutical composition and/or to discuss taking a statinpharmaceutical composition with a medical professional. If the subject'sanswer indicates their triglyceride level is intermediately elevated(e.g., between 175 mg/dL and 500 mg/dL), the device creates a record(813-4) indicating that the user has a risk enhancing factor. If thesubject's answer indicates their triglyceride level is slightly elevated(e.g., between 150 mg/dL and 175 mg/dL), the device creates a record(815-2) indicating that the user has an indicator of metabolic disease.

When the triglyceride filter is not fired, the device proceeds byprompting the subject to provide information about blood pressure andapplies (832) the answer received from the subject to a blood pressurefilter (e.g., filter 216-9 of FIG. 3A and/or filter 9 a in Table 2).When the blood pressure filter is fired (e.g., when the answer indicatesthe subject has a systolic blood pressure of less an 90 mmHg or greaterthan 180 mmHg, or the subject has a diastolic blood pressure of greaterthan 120 mmHg), the device terminates (803) the qualification processwithout authorizing provision of the statin pharmaceutical composition,and, optionally, transmits advice for the subject as to why they shouldnot use a statin pharmaceutical composition and/or to seek immediatemedical attention for hypertensive crisis (e.g., when the subjectindicates they have a systolic blood pressure of greater than 180 mmHgor a diastolic blood pressure of greater than 120 mmHg). If thesubject's answer indicates their systolic blood pressure or diastolicblood pressure is moderately elevated (e.g., a systolic blood pressureof between 130 mmHg and 180 mmHg or a diastolic blood pressure ofbetween 85 mmHg and 120 mmHg), the device creates a record (815-3)indicating that the user has an indicator of metabolic disease.

When the blood pressure filter is not fired, the device proceeds withthe qualification process, prompting the subject to provide informationabout whether they are currently taking blood pressure medication (836),whether they have diabetes (840), and their history of smoking (842). Ifthe subject's answers indicate they are currently taking a bloodpressure medication, and the subject did not have a blood pressureindicative of metabolic disease (e.g., no record was created (815-3), asdescribed above), the device creates a record (815-3) indicating thatthe user has an indicator of metabolic disease. The device thencalculates an atherosclerotic cardiovascular disease (ASCVD) event riskfor the subject (e.g., based on the answers to previous prompts,including characteristics discussed above with respect to Table 3) andapplies (844) the calculated risk to an ASCVD pooled cohort equationfilter (e.g., filter 216-10 of FIG. 3A and/or filter 10 a in Table 2).When the ASCVD pooled cohort equation filter is fired (e.g., when therisk of an ASCVD event is less than 5% or at least 20%), the deviceterminates (803 or 805) the qualification process without authorizingprovision of the statin pharmaceutical composition and, optionally,transmits advice to the user to discuss taking a statin pharmaceuticalcomposition with a medical professional (e.g., where their risk of anASCVD event is at least 20%).

In some embodiments, when the subject's risk of an ASCVD event is belowa floor risk threshold, that would otherwise fire the ASCVD pooledcohort equation filter, the device evaluates whether the subject shouldstill be eligible for provision of the statin pharmaceutical compositionbecause of increased risk associated with diabetes. The device promptsthe subject to indicate whether they have diabetes and then evaluates(846-b) the answer in view of the subject's gender (848-b) and age(850-b). When the device determines the subject has an increased risk ofan ASCVD event, the device bypasses firing the ASCVD filter.

Similarly, in some embodiments, when the subject's risk of an ASCVDevent is between a floor risk threshold and a ceiling risk threshold,that would otherwise not file the ASCVD pooled cohort equation filter,the device evaluates whether the subject should seek further guidancefrom a medical professional because of increased risk associated withdiabetes. The device prompts the subject to indicate whether they havediabetes and then evaluates (846-a) the answer in view of the subject'sgender (848-a) and age (850-a). When the device determines the subjecthas an increased risk of an ASCVD event, the device fires the ASCVDpooled cohort equation filter and the device terminates (805) thequalification process without authorizing provision of the statinpharmaceutical composition and, optionally, transmits advice to the userto discuss taking a statin pharmaceutical composition with a medicalprofessional.

Alternatively, when the device has followed bypass path B, the devicebypasses the total cholesterol filter, the LDL cholesterol filter, theHDL cholesterol filter, the triglyceride filter, the blood pressurefilter, and the ASCVD pooled cohort equation filter, as described above.Rather, the device proceeds by prompting the subject to provideinformation about their LDL cholesterol level and then applies (826-b)the answer to an alternate LDL cholesterol filter (e.g., an alternateversion of filter 216-6 of FIG. 3A and/or filter 6 a in Table 2). Whenthe alternative LDL cholesterol filter is fired (e.g., when the subjectindicates an LDL cholesterol level of less than 70 mg/dL or at least 190mg/dL), the device terminates (803 or 805) the qualification processwithout authorizing provision of the statin pharmaceutical compositionand, optionally, transmits advice to the user as to why they should nottake statin pharmaceutical composition and/or to discuss taking a statinpharmaceutical composition with a medical professional (e.g., wheretheir LDL cholesterol level is at least 190 mg/dL). When the alternativeLDL cholesterol filter is not fired, the device proceeds by promptingthe subject to provide information about their triglyceride level andapplies (830-b) the answer received from the subject to a triglyceridelevel filter (e.g., an alternate filter 216-8 of FIG. 3A and/or filter 8a in Table 2). When the alternate triglyceride level filter is fired(e.g., when the subject indicates a triglyceride level of at least 500mg/dL), the device terminates (805) the qualification process withoutauthorizing provision of the statin pharmaceutical composition and,optionally, transmits advice to the user as to why they should not takestatin pharmaceutical composition and/or to discuss taking a statinpharmaceutical composition with a medical professional.

When the ASCVD pooled cohort equation filter or alternate triglyceridelevel filter is not fired, the proceeds with the qualification process,prompting the subject to indicate whether they have had a livercondition and then applies (852) the answer received from the subject toa liver condition filter (e.g., filter 216-11 in FIG. 3A and/or filter11 a in Table 2). When the liver condition filter is fired (e.g., whenthe answer indicates the subject has had a liver condition), the devicethe terminates (803) the qualification process without authorizingprovision of the statin pharmaceutical composition and, optionally,transmits advice to the user as to why they should not take statinpharmaceutical composition.

When the liver condition filter is not fired, the device proceeds withthe qualification process, prompting the subject to indicate whetherthey have a kidney problem and applies (854) the answer received fromthe subject to a kidney disorder filter (e.g., filter 5 b in Table 4).When the kidney disorder filter is fired (e.g., when the answerindicates the subject has had a kidney problem), the device initiates(811-1) an override procedure (e.g., creating a record indicating thatthe user must confirm they have discussed taking a statin pharmaceuticalcomposition with a health care provider).

The device proceeds with the qualification process, prompting thesubject to indicate their alcohol consumption status and applies (856)the answer received from the subject to alcohol consumption filter(e.g., filter 222-1 of FIG. 3B and/or filter 1 b of Table 4). When thealcohol consumption filter is fired (e.g., when the answer indicates thesubject consumes alcoholic drinks at a frequency above a ceilingfrequency), the device initiates (811-2) an override procedure (e.g.,creating a record indicating that the user must confirm they havediscussed taking a statin pharmaceutical composition with a health careprovider).

The device proceeds with the qualification process, prompting thesubject to indicate whether the subject has had an adverse reaction to acholesterol lowering drug and applies (858) the answer received from thesubject to an adverse reaction filter (e.g., filter 222-2 of FIG. 3Band/or one of filters 2 b and 4 b in Table 4). When the adverse reactionfilter is fired (e.g., when the answer indicates the subject has had anadverse reaction to a cholesterol lowering medication), the deviceinitiates (811-3) an override procedure (e.g., creating a recordindicating that the user must confirm they have discussed taking astatin pharmaceutical composition with a health care provider).

The device proceeds with the qualification process, prompting thesubject to indicate if they are taking a composition that interacts withthe statin pharmaceutical composition, and/or evaluates previous answersabout the medications the subject is taking, and then applies (860) theanswer received from the subject to a moderate drug interaction filter(e.g., filter 222-3 of FIG. 3B and/or filter 3 b in Table 4). When themoderate drug interaction filter is fired (e.g., when the answerindicates the subject is taking a medication that constitutes a riskfactor for co-administration of the statin pharmaceutical composition),the device initiates (811-4) an override procedure (e.g., creating arecord indicating that the user must confirm they have discussed takinga statin pharmaceutical composition with a health care provider).

The device then proceeds by evaluating whether the subject has riskenhancing factors sufficient to justify treatment with the statinpharmaceutical composition. The device first applies (862) all recordscreated (813) for risk enhancing factors based on the subject's previousanswers (e.g., relating to their race, family history of prematurecardiovascular disease, LDL cholesterol level, and triglyceride level)to a risk enhancing factor filter (e.g., filter 12 a in Table 2). Whenthe subject's information collected to that point does not indicate thesubject has a risk enhancing factor, justifying statin therapy, thedevice begins determining if the subject has other risk enhancingfactors.

For instance, the device evaluates (864-a) whether the subject hasmetabolic syndrome based on the subject's previous answers (e.g.,relating to HDL cholesterol level, triglyceride level, and bloodpressure). When it's determined the subject has metabolic syndrome, thedevice creates a record (813-5) indicating that the user has a riskenhancing factor, and proceeds along pathway J. If not, the deviceevaluates (864-b) whether the subject has at least two indicators ofmetabolic syndrome based on the subject's previous answers. When it'sdetermined the subject has at least two indicators of metabolicsyndrome, the device determines (866) whether the subject is a male orfemale, prompts the user to indicate their waist size, and evaluates(868) the answer. When the answer indicates the subject has a waist sizeindicative of metabolic syndrome, the device creates a record (813-5)indicating that the user has a risk enhancing factor, and proceeds alongpathway J.

Similarly, the device prompts the subject to indicate whether they havean inflammatory disease and evaluates (870) the answer received from thesubject. When the answer indicates the subject has an inflammatorydisease, the device creates a record (813-6) indicating that the userhas a risk enhancing factor, and proceeds along pathway J.

Similarly, the device determines (872) whether the subject is female,and then prompts the subject to indicate whether they have experiencedpreeclampsia and evaluates (874) the answer received from the subject.When the answer indicates the subject has experienced preeclampsia, thedevice creates a record (813-7) indicating that the user has a riskenhancing factor, and proceeds along pathway J. Optionally, the devicethen prompts the subject to indicate whether they have experiencedpremature menopause and evaluates (874) the answer received from thesubject. When the answer indicates the subject has premature menopause,the device creates a record (813-8) indicating that the user has a riskenhancing factor, and proceeds along pathway J.

Similarly, the device determines (878) whether the subject knows theirC-reactive protein and/or coronary artery calcium levels. When thescores are known, the device prompts the user to indicate theirC-reactive protein level and evaluates (880) the answer received fromthe subject. When the answer indicates the subject has elevatedC-reactive protein levels, the device creates a record (813-9)indicating that the user has a risk enhancing factor, and proceeds alongpathway J. Optionally, the device then prompts the user to indicatetheir coronary artery calcium level and evaluates (882) the answerreceived from the subject. When the answer indicates the subject has asufficiently elevated coronary artery calcium level score (e.g., anycoronary artery calcium for an older subject or significantly elevatedcoronary artery calcium levels in younger subjects), the device createsa record (813-10) indicating that the user has a risk enhancing factor,and proceeds along pathway J.

When the risk enhancing factor filter is fired (e.g., when the answersindicate the subject still does not have sufficient risk enhancingfactors to justify statin therapy), the device the terminates (805) thequalification process without authorizing provision of the statinpharmaceutical composition and, optionally, transmits advice to the useras to why they should not take statin pharmaceutical composition.

When the risk enhancing factor filter is not fired, the device proceedsalong pathway J by prompting the subject to confirm the answers theyhave provided (884). Upon confirmation, the device proceeds with thequalification process, determining (886) whether the override procedurehas been triggered (e.g., by firing one or more of the kidney diseasefilter, the alcohol consumption filter, the adverse reaction filter, orthe moderate drug interaction filter). If the override procedure hasbeen triggered, the device prompts (817) the user to confirm that theyhave spoken with a medical professional about taking a statinpharmaceutical composition (e.g., in view of the underlying risk factorthat triggered the respective filter) and the medical professionalrecommended taking the statin pharmaceutical composition. If the user'sresponse indicates they have not spoken with a medical professional orthe medical professional did not recommend taking the statinpharmaceutical composition, the device terminates (805) the process and,optionally, transmits advice for the subject to consult a medicalprofessional.

If the override procedure was not triggered, or the override procedurewas triggered and the subject's response indicated that a medicalprofessional recommended they take a statin pharmaceutical composition(e.g., in view of the underlying risk factor triggering the overrideprocedure), the device transmits (888) a drug facts label for the statinpharmaceutical composition and prompts the user to read the drug factslabel. If the subject confirms they have read the drug facts label, thedevice proceeds to authorize (890) purchase of the statin pharmaceuticalcomposition.

FIG. 9 illustrates an example method for qualifying a subject for are-fill (e.g., a re-assessment) of a provision for an over-the-counterstatin pharmaceutical composition (e.g., following a prescription from amedical professional or initial qualification for an over-the-counterstatin pharmaceutical composition, e.g., according to a method describedherein). Referring to FIG. 9, the device determines the period of timethat has elapsed since the subject most recently received provision ofthe statin pharmaceutical composition and evaluates (902) whether aminimum amount of time has passed. If a minimum amount of time has notpassed since the subject last received a provision of the statinpharmaceutical agent, the device terminates (901) the re-qualificationprocess without authorizing provision of the statin pharmaceuticalcomposition and, optionally, transmits advice to the user to return at alater date (e.g., once the floor elapsed period of time has passed). Thedevice then evaluates (904) whether more than a maximum amount of timehas passed. If a maximum amount of time has passed since the subjectlast received a provision of the statin pharmaceutical agent, the deviceterminates (905) and, optionally, directs the subject to retake theinitial qualification assessment (e.g., as described with respect toFIGS. 4 and 8 above).

When a minimum amount of time, but not a maximum amount of time, haspassed since the subject last received a provision of the statinpharmaceutical agent, the device proceeds with the qualificationprocess, prompting the subject to indicate whether the subject has had adocumented cardiac event since receiving their last provision of thestatin pharmaceutical agent, and then applies (908) the answer receivedfrom the subject to a cardiac event filter (e.g., filter 216-12 of FIG.3B). In some embodiments, when the cardiac event filter is fired (e.g.,when the answer indicates the subject has had a documented cardiacevent), the device creates (990-1) a record of an adverse event (e.g.,aggregated in an adverse event data store having records of adverseevents from a plurality of users), terminates (907) the qualificationprocess without authorizing re-provision of the statin pharmaceuticalcomposition and, optionally, transmits advice to the user as to why theyshould not take the statin pharmaceutical composition.

When the cardiac event filter is not fired, the device proceeds with thequalification process, by evaluating whether the statin pharmaceuticalagent has sufficiently lowered the subject's cholesterol level. Thedevice determines (910) whether it was already confirmed that thesubject's cholesterol level was lowered, e.g., by evaluating records(e.g., in subject profile data store 232) from previous reorderrequests. When it was previously confirmed that taking the statinpharmaceutical agent has lowered the subject's cholesterol levels, thedevice bypasses additional evaluation of the subject's cholesterol level(e.g., bypasses a cholesterol status filter). When it was not previouslyconfirmed that taking the statin pharmaceutical agent has lowered thesubject's cholesterol level, the device prompts the subject to indicatewhether they retested their cholesterol level since receiving aprovision of the statin pharmaceutical agent and evaluates (912) theiranswer. When the answer indicates the subject has not retested theircholesterol since receiving a provision of the statin pharmaceuticalcomposition, the device bypasses additional evaluation of the subject'scholesterol level. When the answer indicates the subject has retestedtheir cholesterol since receiving a provision of the statinpharmaceutical composition, the device prompts the subject to provideinformation about their retested cholesterol level and applies (916)their answer(s) to a cholesterol status filter (e.g., filter 216-13 ofFIG. 3B and/or filter 2 c in Table 6). When the cholesterol statusfilter is fired (e.g., when the answer indicates the subject'scholesterol level has not decreased by at least 10% since beginningstatin therapy), the device terminates (907) the requalification processwithout authorizing provision of the statin pharmaceutical agent and,optionally, transmits advice to the user as to why they should not takethe statin pharmaceutical composition.

When the cholesterol status filter is not fired, the device proceedswith the requalification process, evaluating whether the subject hasbecome pregnant or started breast feeding. The device determines (918)the gender of the subject (e.g., by evaluating information previouslyprovided to the system, e.g., in subject profile data store 232). Whenthe subject is a male, the device bypasses further evaluation of whetherthe subject has become pregnant (e.g., bypasses the pregnancy filter).When the subject is female, the device determines (919) the age of thesubject, (e.g., by evaluating information previously provided to thesystem, e.g., in subject profile data store 232). When the subject isnot of child-bearing age (e.g., over 60 years of age), the subjectbypasses further evaluation of whether the subject has become pregnant(e.g., bypasses the pregnancy filter). When the subject is female and ofchild bearing age, the device prompts the subject to indicate theirpregnancy status and then applies (920) the answer to a pregnancy filter(e.g., filter 216-14 of FIG. 3B and/or filter 3 c in Table 6). When thepregnancy filter is fired (e.g., when the answer indicates the subjectis pregnant or breastfeeding), the device creates (990-2) a record of anadverse event (e.g., aggregated in an adverse event data store havingrecords of adverse events from a plurality of users), terminates (909)the requalification process without authorizing provision of the statinpharmaceutical agent and, optionally, transmits advice to the user as towhy they should not take the statin pharmaceutical composition.

When the pregnancy filter was bypassed or not fired, the device proceedsby prompting the subject to provide information related to their currentpharmaceutical composition use and then applies (922) the answer to asevere drug interaction filter (e.g., filter 216-15 of FIG. 3B and/orfilter 4 c in Table 6). When the severe drug interaction filter is fired(e.g., when the answer indicates the subject is taking a drug that iscontraindicated for co-administration with the statin pharmaceuticalcomposition), the device terminates (907) the requalification processwithout authorizing provision of the statin pharmaceutical compositionand, optionally, transmits advice to the user as to why they should nottake the statin pharmaceutical composition.

When the severe drug interaction filter is not fired, the deviceproceeds by prompting the subject to indicate whether they havedeveloped a liver condition and then applies (924) the answer receivedfrom the subject to a liver condition filter. When the liver conditionfilter is fired (e.g., when the answer indicates the subject hasdeveloped a liver condition since receiving their last provision of thestatin pharmaceutical composition), the device creates (990-3) a recordof an adverse event (e.g., aggregated in an adverse event data storehaving records of adverse events from a plurality of users) andterminates (909) the requalification process without authorizing aprovision of the statin pharmaceutical composition and, optionally,transmits advice to the user to discuss receiving the statinpharmaceutical composition with a medical professional.

When the liver condition filter is not fired, the device proceeds withthe qualification process, prompting the subject to indicate whetherthey have experienced unexplained muscle weakness or pain and thenapplies (926) the answer received from the subject to a muscleirregularity filter. When the muscle irregularity filter is fired (e.g.,when the answer indicates the subject has experienced unexplained muscleweakness or pain since receiving their last provision of the statinpharmaceutical composition), the device creates (990-4) a record of anadverse event (e.g., aggregated in an adverse event data store havingrecords of adverse events from a plurality of users) and terminates(909) the requalification process without authorizing a provision of thestatin pharmaceutical composition and, optionally, transmits advice tothe user to discuss receiving the statin pharmaceutical composition witha medical professional.

When the muscle irregularity filter is not fired, the device proceeds byevaluating (928) whether the subject previously reported a kidneyproblem (e.g., by evaluating information previously provided to thesystem, e.g., in subject profile data store 232). When the subject hasnot previously reported kidney problems, the device prompts the subjectto indicate whether they have developed a kidney problem since receivingtheir last provision of the statin pharmaceutical composition andapplies (930) the answer to a kidney disorder filter (e.g., filter 3 din Table 7). When the answer indicates the subject has developed kidneydisease, the device the device creates (990-5) a record of an adverseevent (e.g., aggregated in an adverse event data store having records ofadverse events from a plurality of users) and initiates (911-1) anoverride procedure (e.g., creates a record indicating that the user mustconfirm they have discussed taking a statin pharmaceutical compositionwith a health care provider). When the subject has previously reportedkidney problems, the device prompts the subject to indicate whether theyhave experienced worsening of their symptoms since receiving their lastprovision of the statin pharmaceutical composition and applies (932) theanswer to a kidney disorder filter (e.g., filter 3 d in Table 7). Whenthe answer indicates the subject's kidney disease has progressed, thedevice the device creates (990-6) a record of an adverse event (e.g.,aggregated in an adverse event data store having records of adverseevents from a plurality of users) and initiates (911-2) an overrideprocedure (e.g., creates a record indicating that the user must confirmthey have discussed taking a statin pharmaceutical composition with ahealth care provider).

The device proceeds then with the qualification process, prompting thesubject to provide an alcohol consumption status and then applies (934)the answer to an alcohol consumption filter (e.g., filter 222-5 of FIG.3B and/or filter 1 d in Table 7). When the alcohol consumption filter isfired (e.g., when the answer indicates the subject consumes more than athreshold amount of alcohol), the device initiates (911-3) an overrideprocedure (e.g., creates a record indicating that the user must confirmthey have discussed taking a statin pharmaceutical composition with ahealth care provider).

The device proceeds with the qualification process, evaluating (936)whether the subject is currently taking any medications that moderatelyinteract with the statin pharmaceutical composition, using a moderatedrug interaction filter (e.g., filter 222-6 of FIG. 3B and/or filter 2 din Table 7), e.g., by evaluating answers provided in conjunction withthe severed drug interaction filter and/or by prompting the subject formore information about what medications they are currently taking. Whenthe moderate drug interaction filter is fired (e.g., when the subject'sanswers indicate they are currently taking a medication that moderatelyinteracts with the statin pharmaceutical composition), the deviceinitiates (911-3) an override procedure (e.g., creates a recordindicating that the user must confirm they have discussed taking astatin pharmaceutical composition with a health care provider).

The device then proceeds with the qualification process, prompting thesubject to confirm the answers they have provided (940). Uponconfirmation, the device proceeds by determining (942) whether theoverride procedure has been triggered (e.g., by firing one or more ofthe alcohol consumption filter, moderate drug interaction filter, orkidney disorder filter). If the override procedure has been triggered,the device prompts (913) the user to confirm that they have spoken witha medical professional about taking a statin pharmaceutical agent (e.g.,in view of the underlying risk factor that triggered the respectivefilter) and the medical professional recommended taking the statinpharmaceutical composition. If the user's response indicates they havenot spoken with a medical professional or the medical professional didnot recommend taking the statin pharmaceutical composition, the deviceterminates (909) the process and, optionally, transmits advice for thesubject to consult a medical professional.

If the override procedure was not triggered, or the override procedurewas triggered and the subject's response indicated that a medicalprofessional recommended they take a statin pharmaceutical composition(e.g., in view of the underlying risk factor triggering the overrideprocedure), the device transmits (944) a drug facts label for the statinpharmaceutical composition and prompts the user to read the drug factslabel. If the subject confirms they have read the drug facts label, thedevice proceeds to authorize (946) repurchase of the statinpharmaceutical composition.

Specific Embodiments

In one aspect, the disclosure provides methods, software, and computersystems for qualifying a human subject for an over-the-counter provisionof a statin pharmaceutical composition to lower cholesterol, e.g.,treating or preventing heart disease. In one embodiment, a computersystem (e.g., computer system 250 in FIG. 2) includes instructions forproviding an assessment survey of the subject (e.g., assessment module252 in FIG. 2) to obtain an information set (e.g., first informationset) about the subject necessary to run against at least two series offilters (e.g., a first plurality of assessment filters 214-1 and asecond plurality of assessment filters 220-1). The computer system alsoincludes instructions for running the information set against theassessment filters. Filters 216 in the first plurality of assessmentfilters 214-1 prevent authorization for provision of the OTC statinwhere the subject's information set identifies a contraindication forthe OTC statin. Filters 222 in the second plurality of assessmentfilters 220-1 generate a warning 226 where the subject's information setidentifies a risk factor for the OTC statin. In some embodiments, thewarning 226 includes a prompt requiring the subject to confirm they havediscussed the risk factor with a physician in order to proceed withqualification for the OTC statin.

In some embodiments, the computer system includes instructions forproceeding with a fulfillment process when no filter in the firstplurality of assessment filters has been fired and the subject hasacknowledged each warning associated with each filter in the secondplurality of assessment filters that was fired. In some embodiments, thefulfillment process includes storing an indication in a subject profileof an initial order for the statin pharmaceutical composition,communicating an over the counter drug facts label for the statinpharmaceutical composition to the subject, and authorizing, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, provision of the statin pharmaceuticalcomposition to the subject

In one aspect, the disclosure provides methods, software, and computersystems for qualifying a human subject for a re-order (e.g.,re-assessment) for an over-the-counter provision of a statinpharmaceutical composition to lower cholesterol, e.g., treating orpreventing heart disease. In one embodiment, a computer system includesinstructions, responsive to receiving a re-order request from thesubject for the statin pharmaceutical composition, performing are-fulfillment procedure (e.g., re-assessment procedure) including, forproviding a re-assessment survey of the subject to obtain an informationset (e.g., second information set) for qualifying the subject for there-order, e.g., associated with at least two series of filters (e.g., afirst plurality of re-assessment filters 214-2 and a second plurality ofre-assessment filters 220-2). The computer system also includesinstructions for running the information set against the re-assessmentfilters. Filters 216 in the first plurality of re-assessment filtersprevent authorization for delivery of the OTC statin where the subject'sinformation set identifies a contraindication for the OTC statin.Filters 222 in the second plurality of re-assessment filters generate awarning 226 where the subject's information set identifies a risk factorfor the OTC statin. In some embodiments, the warning 226 includes aprompt requiring the subject to confirm they have discussed the riskfactor with a physician in order to proceed with qualification for theOTC statin.

In some embodiments, the computer system also includes instructions forproceeding with a re-fulfillment process when no filters in the firstplurality of reassessment filters was fired and the subject acknowledgeseach warning associated with each filter in the second plurality ofreassessment filters that was fired. In some embodiments, there-fulfillment process includes storing an indication in a subjectprofile of a re-order for the statin pharmaceutical composition,communicating an over-the-counter drug facts label 230 for the statinpharmaceutical composition to the subject and, upon confirmation thatthe over-the-counter drug facts label has been received and read,authorizing provision of the OTC statin pharmaceutical composition tothe subject.

In one aspect, the disclosure provides a method for qualifying a humansubject for an over-the-counter provision of a statin pharmaceuticalcomposition. The method includes providing an assessment survey forobtaining a first information set from the subject. The method includesapplying an algorithm to the first information set. The algorithm runsall or a portion of the first information set against a first pluralityof assessment filters. The subject is deemed not qualified for a statintreatment when a respective filter in the first plurality of assessmentfilters is fired and the method is terminated without authorizingprovision of the statin pharmaceutical composition to the subject. Thealgorithm also runs all or a portion of the first information setagainst a second plurality of assessment filters. When a respectivefilter in the second plurality of assessment filters is fired, thesubject is provided with a warning corresponding to the respectivefilter. Further, the algorithm obtains acknowledgment from the subjectconfirming that the subject has discussed the risk factor associatedwith each warning issued to the subject by any filter in the secondplurality of assessment filters with a physician. The algorithm thenproceeds with a fulfillment process when no filter in the firstplurality of assessment filters has been fired and the subject hasacknowledged each warning associated with each filter in the secondplurality of assessment filters that was fired. The fulfillment processincludes storing an indication in a subject profile of an initial orderfor the statin pharmaceutical composition, communicating an over thecounter drug facts label for the statin pharmaceutical composition tothe subject, and authorizing, upon confirmation from the subject thatthe over the counter drug facts label has been received and read,provision of the statin pharmaceutical composition to the subject.

In some embodiments, the information set includes information selectedfrom the survey results listed in Table 1. In one embodiment, theinformation set includes: a sex of the subject, an age of the subject,when the subject is a female, whether the subject is pregnant orbreastfeeding, whether the subject is taking one or more compositionsthat interact with the statin pharmaceutical composition, whether thesubject has ever had a cardiac event, a total cholesterol level of thesubject, a LDL cholesterol level of the subject, a HDL cholesterol levelof the subject, a triglyceride level of the subject, a systolic bloodpressure of the subject, a diastolic blood pressure of the subject,whether the subject has a liver condition, an alcohol consumption statusof the subject, and whether the subject has had an adverse reaction to acholesterol lowering composition.

In some embodiments, the first plurality of assessment filters includesa plurality of assessment filters selected from the filters listed inTable 2. In one embodiment, the first plurality of assessment filtersincludes an age filter, a pregnancy filter, a severe drug interactionfilter, a cardiac event filter, a total cholesterol filter, a LDLcholesterol filter, a HDL cholesterol filter, a triglyceride levelfilter, a blood pressure filter, an ASCVD risk pooled cohort equationfilter, and a liver condition filter.

In some embodiments, the second plurality of assessment filters includesa plurality of assessment filters selected from the filters listed inTable 4. In one embodiment, the second plurality of assessment filtersincludes an alcohol consumption filter, an adverse reaction filter, anda moderate drug interaction filter.

In some embodiments, the first and second plurality of assessmentfilters includes filters selected from the filters listed in Table 8. Insome embodiments, the first plurality of assessment filters include afirst sub-plurality of the filters listed in Table 8, for example, 2, 3,4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or all 15 of the filters listed inTable 8, and the second plurality of assessment filters include a secondsub-plurality of the filters listed in Table 8, which is different fromthe first sub-plurality of filters, for example, 2, 3, 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, or all 15 of the filters listed in Table 8. In someembodiments, each of the filters in the first sub-plurality of filtersis different from each of the filters in the second sub-plurality offilters (e.g., no filter listed in Table 8 is included in both the firstsub-plurality and the second sub-plurality of filters). In someembodiments, a system for qualifying a subject for delivery of aprovision of an over-the-counter statin pharmaceutical compositionincludes instructions for applying only one plurality of filters, e.g.,only filters of a first plurality of assessment filters. In someembodiments, where the method, system, or software applies a singleplurality of filters, the plurality of filters includes a plurality offilters selected from the filters listed in Table 8, e.g., at least 2,3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or all 15 of the filters listedin Table 8. In some embodiments, where a filter listed in Table 8corresponds to a filter listed in Table 2 or Table 4, a threshold levelsufficient to fire the corresponding filter listed in Table 2 or Table4, as described in detail above, is sufficient to fire the filter listedin Table 8.

TABLE 8 Example Assessment Filters Filter Exemplary Criteria  1e an agefilter  2e a pregnancy filter  3e a severe drug interaction filter  4e acardiac event filter  5e a total cholesterol filter  6e a LDLcholesterol filter  7e a HDL cholesterol filter  8e a triglyceridefilter  9e a blood pressure filter 10e an ASCVD risk pooled cohortequation filter 11e a liver condition filter 12e a risk enhancing factorfilter 13e an alcohol consumption filter 14e an adverse reaction filter15e a moderate drug interaction filter

In one aspect, the disclosure provides methods, software, and computersystems for qualifying a human subject for a re-order (e.g., are-assessment) for an over-the-counter provision of a statinpharmaceutical composition to lower cholesterol, e.g., treating orpreventing heart disease. In one embodiment, a method includes providinga re-assessment survey for obtaining a second information set from thesubject. The method includes applying an algorithm to the secondinformation set. The algorithm runs all or a portion of the secondinformation set against a first plurality of re-assessment filters. Thesubject is deemed not qualified for a statin treatment when a respectivefilter in the first plurality of re-assessment filters is fired and themethod is terminated without authorizing provision of the statinpharmaceutical composition to the subject. The algorithm also runs allor a portion of the second information set against a second plurality ofre-assessment filters. When a respective filter in the second pluralityof re-assessment filters is fired, the subject is provided with awarning corresponding to the respective filter. Further, the algorithmobtains acknowledgment from the subject confirming that the subject hasdiscussed the risk factor associated with each warning issued to thesubject by any filter in the second plurality of re-assessment filterswith a physician. The algorithm then proceeds with a re-fulfillmentprocess when no filter in the first plurality of re-assessment filtershas been fired and the subject has acknowledged each warning associatedwith each filter in the second plurality of re-assessment filters thatwas fired. The re-fulfillment process includes storing an indication ina subject profile of a re-order for the statin pharmaceuticalcomposition, communicating an over the counter drug facts label for thestatin pharmaceutical composition to the subject, and authorizing, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, provision of the statin pharmaceuticalcomposition to the subject.

In some embodiments, the first plurality of re-assessment filtersincludes one or more filters listed in Table 6. In some embodiments, thefirst plurality of re-assessment filters includes a cardiac eventfilter, a cholesterol status filter, a pregnancy filter, a severe druginteraction filter, a liver condition filter, and a muscle irregularityfilter.

In some embodiments, the second plurality of re-assessment filtersincludes one or more filters listed in Table 7. In some embodiments, thesecond plurality of re-assessment filters includes an alcoholconsumption filter and a moderate drug interaction filter.

In some embodiments, the first and second pluralities of re-assessmentfilters includes filters selected from the filters listed in Table 9. Insome embodiments, the first plurality of re-assessment filters includesa first sub-plurality of the filters listed in Table 9, for example, 2,3, 4, 5, 6, 7, 8, or all 9 of the filters listed in Table 9, and thesecond plurality of re-assessment filters includes a secondsub-plurality of the filters listed in Table 9, which is different fromthe first sub-plurality of filters, for example, 2, 3, 4, 5, 6, 7, 8, orall 9 of the filters listed in Table 9. In some embodiments, each of thefilters in the first sub-plurality of filters is different from each ofthe filters in the second sub-plurality of filters (e.g., no filterlisted in Table 9 is included in both the first sub-plurality and thesecond sub-plurality of filters). In some embodiments, a system forqualifying a subject for provision of an over-the-counter statinpharmaceutical composition includes instructions for applying only oneplurality of re-assessment filters, e.g., only filters of a singleplurality of re-assessment filters. In some embodiments, where themethod, system, or software applies a single plurality of re-assessmentfilters, the plurality of re-assessment filters includes a plurality ofre-assessment filters selected from the filters listed in Table 9, e.g.,at least 2, 3, 4, 5, 6, 7, 8, or all 9 of the filters listed in Table 9.In some embodiments, where a filter listed in Table 9 corresponds to afilter listed in Table 2, Table 4, Table 6, or Table 7, a thresholdlevel sufficient to fire the corresponding filter listed in Table 2,Table 4, Table 6, or Table 7, as described in detail above, issufficient to fire the listed in Table 9.

TABLE 9 Example Re-assessment Filters Filter Exemplary Criteria 1f acardiac event filter 2f a cholesterol status filter 3f a pregnancyfilter 4f a severe drug interaction filter 5f a liver condition filter6f a muscle irregularity filter 7f an alcohol consumption filter 8f amoderate drug interaction filter 9f A kidney disorder filter

In one aspect, the present disclosure provides a method for qualifying ahuman subject for an over-the-counter provision of a statinpharmaceutical composition. The method includes A) providing anassessment survey for obtaining a first information set from thesubject, via a computer system having a processor programed to performthe assessment survey. The first information set including: a sex of thesubject, an age of the subject, when the subject is a female, whetherthe subject is pregnant or breastfeeding, whether the subject is takingone or more compositions that interact with the statin pharmaceuticalcomposition, whether the subject has ever had a cardiac event, a totalcholesterol level of the subject, a low-density lipoprotein (LDL)cholesterol level of the subject, a high-density lipoprotein (HDL)cholesterol level of the subject, a triglyceride level of the subject, asystolic blood pressure of the subject, a diastolic blood pressure ofthe subject, whether the subject has a liver condition, an alcoholconsumption status of the subject, and whether the subject has had anadverse reaction to a cholesterol lowering composition. The methodincludes B) applying an algorithm to the first information set, via acomputer system having a processor programed to perform the algorithm.The algorithm i) runs all or a portion of the first information setagainst a first plurality of assessment filters. The subject is deemednot qualified for a statin treatment when a respective filter in thefirst plurality of assessment filters is fired and the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject. The first plurality of assessment filtersincludes: an age filter that is fired at least when the firstinformation set indicates the age of the subject fails to satisfy an agethreshold for receiving the statin pharmaceutical composition, when thesubject is a female, a pregnancy filter that is fired at least when thefirst information set indicates the subject is pregnant orbreastfeeding, a severe drug interaction filter that is fired at leastwhen the first information set indicates the subject is taking one ormore compositions that interact with the statin pharmaceuticalcomposition, wherein the one or more compositions are eachcontraindicated for co-administration with the statin pharmaceuticalcomposition, a cardiac event filter that is fired at least when thefirst information set indicates the subject has had a documented cardiacevent a total cholesterol filter that is fired at least when the firstinformation set indicates the subject has a total cholesterol level thatfails to satisfy a ceiling total cholesterol level threshold, a LDLcholesterol filter that is fired at least when the first information setindicates the subject has a LDL cholesterol level that fails to satisfya ceiling LDL cholesterol level threshold, a HDL cholesterol filter thatis fired at least when the first information set indicates the subjecthas a HDL cholesterol level that fails to satisfy a ceiling HDLcholesterol level threshold, a triglyceride filter that is fired atleast when the first information set indicates the subject has atriglyceride level that fails to satisfy a ceiling triglyceride levelthreshold, a blood pressure filter that is fired at least when the firstinformation set indicates (i) the systolic blood pressure of the subjectfails to satisfy a ceiling systolic blood pressure threshold or (ii) thediastolic blood pressure of the subject fails to satisfy a ceilingdiastolic blood pressure threshold, an atherosclerotic cardiovasculardisease (ASCVD) risk pooled cohort equation filter that is fired atleast when an ASCVD risk derived from the first information setindicates the ASCVD risk of the subject fails to satisfy a ceiling ASCVDrisk threshold, and a liver condition filter that is fired at least whenthe first information set indicates the subject has a liver condition.The algorithm also ii) runs all or a portion of the first informationset against a second plurality of assessment filters. When a respectivefilter in the second plurality of assessment filters is fired, thesubject is provided with a warning corresponding to the respectivefilter. The second plurality of assessment filters includes an alcoholconsumption filter that is fired at least when the alcohol consumptionstatus of the subject in the first information set fails to satisfy aceiling alcohol consumption threshold, a first adverse reaction filterthat is fired at least when the first information set indicates thesubject has had an adverse reaction to a cholesterol-lowering drug, anda moderate drug interaction filter that is fired at least when the firstinformation set indicates the subject is taking one or more compositionsthat interact with the statin pharmaceutical composition. The one ormore compositions are each associated with a warning, but are notcontraindicated, for co-administration with the statin pharmaceuticalcomposition. The algorithm further iii) obtains acknowledgment from thesubject confirming that the subject has discussed the risk factorassociated with each warning issued to the subject by any filter in thesecond plurality of assessment filters with a physician; and iv)proceeds with a fulfillment process when (a) no filter in the firstplurality of assessment filters has been fired and (b) the subject hasacknowledged each warning associated with each filter in the secondplurality of assessment filters that was fired. The fulfillment processincluding: storing an indication in a subject profile of an initialorder for the statin pharmaceutical composition, communicating an overthe counter drug facts label for the statin pharmaceutical compositionto the subject, and authorizing, upon confirmation from the subject thatthe over the counter drug facts label has been received and read,provision of the statin pharmaceutical composition to the subject.

Initial Assessment

In some embodiments of the initial assessment methods, systems, andsoftware described above, the age filter is fired when the firstinformation set indicates the subject is a woman of childbearing age. Insome embodiments, the age filter is fired when the first information setindicates the subject is less than 20 years of age. In some embodiments,the age filter is fired when the first information set indicates thesubject is less than 20 years of age and male or less than 50 years ofage and female. In some embodiments, the age filter is fired when thefirst information set indicates the age of the subject fails to satisfya ceiling age threshold for receiving the statin pharmaceuticalcomposition. In some embodiments, the age filter is fired when the firstinformation set indicates the subject is more than 75 years of age.

In some embodiments of the initial assessment methods, systems, andsoftware described above the pregnancy filter is fired when the firstinformation set indicates the subject is female and planning on becomingpregnant.

In some embodiments of the initial assessment methods, systems, andsoftware described above the second plurality of assessment filtersincludes a second adverse reaction filter that is fired at least whenthe first information set indicates that subject has had an adversereaction to the cholesterol-lowering composition.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the statin pharmaceutical composition includesan active ingredient selected from the group consisting of fluvastatin,atorvastatin, pitavastatin, and lovastatin, and the severe druginteraction filter is fired at least when the first information setindicates the subject is taking cyclosporine.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the statin pharmaceutical composition includesan active ingredient selected from the group consisting of fluvastatin,lovastatin, and pravastatin, and the severe drug interaction filter isfired at least when the first information set indicates the subject istaking a cholesterol-lowering medication or a triglyceride-loweringmedication.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the statin pharmaceutical composition includesan active ingredient selected from the group consisting of pitavastatin,lovastatin, and simvastatin, and the severe drug interaction filter isfired at least when the first information set indicates the subject istaking an anti-viral protease inhibitor.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the statin pharmaceutical composition includesfluvastatin as an active ingredient, and the severe drug interactionfilter is fired at least when the first information set indicates thesubject is taking warfarin.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the statin pharmaceutical composition includeslovastatin or simvastatin as an active ingredient, and the severe druginteraction filter is fired at least when the first information setindicates the subject is taking a strong CYP3A4 inhibitor.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the statin pharmaceutical composition includesrosuvastatin as an active ingredient, and the severe drug interactionfilter is fired at least when the first information set indicates thesubject is taking a drug selected from the group consisting ofcyclosporine, a cholesterol-lowering medication, a triglyceride-loweringmedication, and warfarin.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the cardiac event filter is fired when thefirst information set indicates the subject has had a heart attack, hada stroke, undergone a heart procedure, or has developed peripheralartery disease. In some embodiments, the cardiac event filter is firedwhen the first information set indicates that the subject is a youngmale without a familial history of premature heart disease.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the total cholesterol filter is fired when thefirst information set indicates the total cholesterol level of thesubject is greater than 320 mg/dL. In some embodiments, the totalcholesterol filter is fired when the first information set indicates thesubject has a total cholesterol level that fails to satisfy a totalcholesterol level threshold. In some embodiments, the total cholesterolfilter is fired when the first information set indicates the totalcholesterol level of the subject is less than 130 mg/dL.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the LDL cholesterol filter is fired when thefirst information set indicates the LDL cholesterol level of the subjectis greater than 190 mg/dL. In some embodiments, the LDL cholesterolfilter is fired when the first information set indicates the subject hasa LDL cholesterol level that fails to satisfy a LDL cholesterol levelthreshold. In some embodiments, the LDL cholesterol filter is fired whenthe first information set indicates the LDL cholesterol level of thesubject is less than 160 mg/dL. In some embodiments, the LDL cholesterolfilter is fired when the first information set indicates the LDLcholesterol level of the subject is less than 160 mg/dL when the subjectis an older male or a female and less than 70 mg/dL when the subject isa younger male with a familial history of premature heart disease.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the HDL cholesterol filter is fired when thefirst information set indicates the HDL cholesterol level of the subjectis greater than 100 mg/dL. In some embodiments, the HDL cholesterolfilter is fired when the first information set indicates the subject hasa HDL cholesterol level that fails to satisfy a HDL cholesterol levelthreshold. In some embodiments, the HDL cholesterol filter is fired whenthe first information set indicates the HDL cholesterol level of thesubject is less than 20 mg/dL.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the triglyceride filter is fired when thefirst information set indicates the triglyceride level of the subject isgreater than 500 mg/dL.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the blood pressure filter is fired when thefirst information set indicates the systolic blood pressure of thesubject is greater than 180 mmHg. In some embodiments, the bloodpressure filter is fired when the first information set indicates thesubject has a systolic blood pressure that fails to satisfy a systolicblood pressure threshold. In some embodiments, the blood pressure filteris fired when the first information set indicates the systolic bloodpressure of the subject is less than 90 mmHg. In some embodiments, theblood pressure filter is fired when the first information set indicatesthe diastolic blood pressure of the subject is greater than 120 mmHg.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the first information set includes a race ofthe subject, whether the subject is taking a high blood pressuretreatment, a diabetes status of the subject, and a smoking status of thesubject. The ASCVD risk pooled cohort equation filter incorporates theage of the subject, the gender of the subject, the race of the subject,the total cholesterol level of the subject, the LDL cholesterol level ofthe subject, the HDL cholesterol level of the subject, the triglyceridelevel of the subject, the systolic blood pressure of the subject, thediastolic blood pressure of the subject, whether the subject is taking amedication for hypertension, the diabetes status of the subject, and thesmoking status of the subject to derive a risk for ASCVD.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the ASCVD risk pooled cohort equation isimplemented as a multivariable Cox proportional hazard regression.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the ASCVD risk pooled cohort equation filteris fired when the first information set indicates the subject has anASCVD risk that is greater than a 20% 10-year risk. In some embodiments,the ASCVD risk pooled cohort equation filter is fired when the firstinformation set indicates the subject has an ASCVD risk that fails tosatisfy an ASCVD risk threshold. In some embodiments, the ASCVD riskpooled cohort equation filter is fired when the first information setindicates the subject has an ASCVD risk that is less than a 5% 10-yearrisk.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the algorithm bypasses firing the ASCVD riskpooled cohort equation filter when the first information set indicates,(i) the subject has an ASCVD risk that fails to satisfy the ASCVD riskthreshold, (ii) the subject has diabetes, and (iii) the age of thesubject satisfies a first ceiling diabetes age threshold for receivingthe statin pharmaceutical composition. In some embodiments, the firstceiling diabetes age threshold for receiving the statin pharmaceuticalcomposition is 50 years of age when the subject is a male and 60 yearsof age when the subject is a female.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the ASCVD risk pooled cohort equation filteris fired when the first information set indicates, (i) the subject hasdiabetes, and (ii) the age of the subject does not satisfy a secondceiling diabetes age threshold for receiving the statin pharmaceuticalcomposition. In some embodiments, the second ceiling diabetes agethreshold for receiving the statin pharmaceutical composition is 50years of age when the subject is a male and 60 years of age when thesubject is a female.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the algorithm bypasses the ASCVD risk pooledcohort equation filter when the first information set indicates when thesubject is a younger male. In some embodiments, the algorithm bypassesthe total cholesterol filter when the first information set indicateswhen the subject is a younger male. In some embodiments, the algorithmbypasses the HDL cholesterol filter when the first information setindicates when the subject is a younger male. In some embodiments, thealgorithm bypasses the blood pressure filter when the first informationset indicates when the subject is a younger male.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the statin pharmaceutical composition includesrosuvastatin as an active ingredient, and the second plurality ofassessment filters includes a kidney disorder filter that is fired atleast when the first information set indicates that the subject haskidney disease.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the statin pharmaceutical composition includesan active ingredient selected from the group consisting of fluvastatin,atorvastatin, and pitavastatin, and the second plurality of filtersincludes a kidney disorder filter that is fired at least when the firstinformation set indicates that the subject has kidney disease.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the ceiling amount of alcohol for firing thealcohol consumption filter is two alcoholic drinks per day.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the statin pharmaceutical composition includesrosuvastatin as an active ingredient, and the moderate drug interactionfilter is fired at least when the first information set indicates thesubject is taking colchicine or an anti-viral protease inhibitor.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the first plurality of assessment filtersincludes a risk enhancing factor filter that is fired unless the firstinformation set indicates that the subject has at least one of aplurality of risk enhancing factors for high cholesterol. In someembodiments, the first plurality of assessment filters includes a riskenhancing factor filter that is fired unless the first information setindicates that the subject has at least two of a plurality of riskenhancing factors for high cholesterol.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the first plurality of assessment filtersincludes a risk enhancing factor filter that is fired when the firstinformation set indicates the subject has an ASCVD risk that fails tosatisfy an intermediate ASCVD risk threshold, unless the firstinformation set indicates the subject has at least one of a plurality ofrisk enhancing factors for high cholesterol.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the first plurality of assessment filtersincludes a risk enhancing factor filter that is fired when the firstinformation set indicates the subject has an ASCVD risk that fails tosatisfy an intermediate ASCVD risk threshold, unless the firstinformation set indicates the subject has at least two of a plurality ofrisk enhancing factors for high cholesterol.

In some embodiments of the initial assessment methods, systems, andsoftware described above, the ASCVD risk of the subject is derived froma pooled cohort algorithm that incorporates the age of the subject, thegender of the subject, the race of the subject, the total cholesterollevel of the subject, the LDL cholesterol level of the subject, the HDLcholesterol level of the subject, the triglyceride level of the subject,the systolic blood pressure of the subject, the diastolic blood pressureof the subject, whether the subject is taking a medication forhypertension, the diabetes status of the subject, and the smoking statusof the subject. In some embodiments, the ASCVD risk is derived from apooled cohort algorithm implementing a multivariable Cox proportionalhazard regression. In some embodiments, the intermediate ASCVD riskthreshold is a 7.5% 10-year risk.

In some embodiments, the plurality of risk enhancing factors thatprevent firing of the risk enhancing factor filter include South Asiandescent, a familial history of premature heart disease, a LDLcholesterol level of at least 160 mg/dL, a triglyceride level of atleast 175 mg/dL, an inflammatory disease, preeclampsia, prematuremenopause, a C-Reactive Protein (CRP) level of at least 2 mg/L, coronaryartery calcium, and metabolic syndrome. In some embodiments, wherein thesubject is deemed to have the metabolic syndrome when the firstinformation set indicates the subject has: (i) an HDL cholesterol levelof less than 40 mg/dL, (ii) a triglyceride level of greater than 150mg/dL, and (iii) a systolic blood pressure of at least 130 mmHg, adiastolic blood pressure of at least 85 mmHg, or a current bloodpressure medication regimen when the subject has a systolic bloodpressure of less than 130 mmHg and a diastolic blood pressure of lessthan 85 mmHg.

In some embodiments, the subject is deemed to have the metabolicsyndrome when the first information set indicates the subject has: (A) awaist circumference of at least 35 inches for a female or at least 40inches for a male, and (B) at least two of: (i) a HDL cholesterol levelof less than 40 mg/dL, (ii) a triglyceride level of greater than 150mg/dL, and (iii) a systolic blood pressure of at least 130 mmHg, adiastolic blood pressure of at least 85 mmHg, or a current bloodpressure medication regimen when the subject has a systolic bloodpressure of less than 130 mmHg and a diastolic blood pressure of lessthan 85 mmHg.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 2.5 mg to 15 mg ofrosuvastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of 5 mg of rosuvastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 20 mg to 40 mg offluvastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 10 mg to 40 mg ofatorvastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 1 mg to 4 mg ofpitavastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 10 mg to 40 mg oflovastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 10 mg to 40 mg ofpravastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 5 mg to 20 mg ofsimvastatin per day.

In some embodiments, the method also includes administering, afterauthorization of the provision, the statin pharmaceutical composition tothe subject.

Reassessment

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the method is terminated without authorizingre-provision of the statin pharmaceutical composition to the subjectwhen more than a threshold period of time has passed since the subjectreceived their first provision of the statin pharmaceutical compositionwithout retesting their cholesterol level. In some embodiments, thethreshold period of time since the subject received their firstprovision of the statin pharmaceutical composition without retestingtheir cholesterol level, for terminating the method, is 90 days.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the method is terminated without authorizingre-provision of the statin pharmaceutical composition to the subjectwhen less than a threshold period of time has passed since the subjectreceived their last provision of the statin pharmaceutical composition.In some embodiments, the subject's last provision of the statinpharmaceutical composition included daily dosages of the statinpharmaceutical composition for a predetermined number of days, and thethreshold period of time since the subject received their last provisionof the statin pharmaceutical composition, for terminating the method, isa period of time greater than half the predetermined number of days.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the cardiac event filter is fired when the secondinformation set indicates the subject had a heart attack, had a stroke,has undergone a heart procedure, or has developed peripheral arterydisease since receiving their last provision of the statinpharmaceutical composition.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the algorithm bypasses the cholesterol status filterwhen the subject reported a reduction of their cholesterol by more thanthe threshold amount during a previous re-order of the statinpharmaceutical composition.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the algorithm bypasses the cholesterol status filterwhen the second information set indicates the subject, (i) has not yetretested their cholesterol following their first provision of the statinpharmaceutical composition, and (ii) has ordered the statinpharmaceutical composition less than three times.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the method is terminated without authorizingre-provision of the statin pharmaceutical composition to the subjectwhen the second information set indicates the subject: (i) has not yetretested their cholesterol following their first provision of the statinpharmaceutical composition, and (ii) has ordered the statinpharmaceutical composition at least three times.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the statin pharmaceutical composition includes anactive ingredient selected from the group consisting of fluvastatin,atorvastatin, pitavastatin, and lovastatin, and the severe druginteraction filter is fired at least when the second information setindicates the subject is taking cyclosporine.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the statin pharmaceutical composition includes anactive ingredient selected from the group consisting of fluvastatin,lovastatin, and pravastatin, and the severe drug interaction filter isfired at least when the second information set indicates the subject istaking a cholesterol-lowering medication or a triglyceride-loweringmedication.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the statin pharmaceutical composition includes anactive ingredient selected from the group consisting of pitavastatin,lovastatin, and simvastatin, and the severe drug interaction filter isfired at least when the second information set indicates the subject istaking an anti-viral protease inhibitor.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the statin pharmaceutical composition includesfluvastatin as an active ingredient, and the severe drug interactionfilter is fired at least when the second information set indicates thesubject is taking warfarin.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the statin pharmaceutical composition includeslovastatin or simvastatin as an active ingredient, and the severe druginteraction filter is fired at least when the second information setindicates the subject is taking a strong CYP3A4 inhibitor.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the statin pharmaceutical composition includesrosuvastatin as an active ingredient, and the severe drug interactionfilter is fired at least when the second information set indicates thesubject is taking a drug selected from the group consisting ofcyclosporine, a cholesterol-lowering medication, a triglyceride-loweringmedication, and warfarin.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the statin pharmaceutical composition includesrosuvastatin as an active ingredient, and the second plurality ofre-assessment filters includes a kidney disorder filter that is fired atleast when the second information set indicates the subject hasdeveloped kidney problems or experienced worsening of a previous kidneyproblem since receiving their last provision of the statinpharmaceutical composition.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the statin pharmaceutical composition includes anactive ingredient selected from the group consisting of fluvastatin,atorvastatin, and pitavastatin, and the second plurality ofre-assessment filters includes a kidney disorder filter that is fired atleast when the second information set indicates the subject hasdeveloped kidney problems or experienced worsening of a previous kidneyproblem since receiving their last provision of the statinpharmaceutical composition.

In some embodiments of the reassessment methods, systems, and softwaredescribed above, the statin pharmaceutical composition includesrosuvastatin as an active ingredient, and the moderate drug interactionfilter is fired at least when the second information set indicates thesubject is taking colchicine or an anti-viral protease inhibitor.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 2.5 mg to 15 mg ofrosuvastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of 5 mg of rosuvastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 20 mg to 40 mg offluvastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 10 mg to 40 mg ofatorvastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 1 mg to 4 mg ofpitavastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 10 mg to 40 mg oflovastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 10 mg to 40 mg ofpravastatin per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 5 mg to 20 mg ofsimvastatin per day.

In some embodiments, the method also includes administering, afterauthorization of the provision, the statin pharmaceutical composition tothe subject.

EXAMPLES

The following examples provide example implementations of the methods,systems, and software described herein for various statin pharmaceuticalcompositions. However, these examples do not imply that these are theonly useful implementations of the methods, systems, and softwaredescribed herein for each individual statin pharmaceutical agent. Theskilled artisan will know how to change each of these implementationsaccording to their particular goals and desired safety profiles, e.g.,based on the identity and/or dosage of the statin active ingredient. Forinstance, kidney disease filters are not included in some of theexamples given below. However, in some embodiments the skilled artisanmay be motivated to add such a filter to a particular system. Forinstance, while renal impairment is not a classical risk factor for lowdose pravastatin pharmaceutical compositions, severe renal impairment isa known predisposition factor for myopathy and, thus, the skilledartisan may choose to implement a kidney disease filter in a system forqualifying patients to receive OTC pravastatin.

Example 1

A computer system is prepared for qualifying a human subject fordelivery of a rosuvastatin pharmaceutical composition (e.g., low-doseCRESTOR) over the counter to treat or prevent an atheroscleroticcardiovascular disease (e.g., by lowering cholesterol).

The computer system includes instructions for conducting a survey of thesubject, to obtain an age of the subject, a gender of the subject, ifthe subject is female, whether they are (i) pregnant, (ii)breastfeeding, or (iii) planning to become pregnant, a race of thesubject, whether the subject is taking one or more medications thatinteract with the statin pharmaceutical composition (e.g., cyclosporine,warfarin, colchicine, lipid-lowering medications such as fibrates,and/or an anti-viral protease inhibitors), whether the subject has everhad an atherosclerotic cardiovascular event or had a heart procedure,whether the subject has a family history of premature ASCVD events, atotal cholesterol level of the subject, an LDL cholesterol level of thesubject, an HDL cholesterol level of the subject, a triglyceride levelof the subject, a systolic blood pressure of the subject, a diastolicblood pressure of the subject, whether the subject is taking amedication for high blood pressure, whether the subject has diabetes,whether the subject is a smoker, whether the subject has or has ever hadliver disease, whether the subject has or has ever had kidney disease,an alcohol consumption status of the subject, and whether the subjecthas ever has an adverse reaction to a cholesterol lowering medication.

The computer system runs survey results against a first series offilters that each prevents authorization for delivery of the OTCrosuvastatin where the subject's survey results identify acontraindication for the OTC rosuvastatin. The first series of filtersincludes an age filter, a pregnancy filter, a severe drug interactionfilter, a cardiac event filter, a total cholesterol level filter, an LDLcholesterol level filter, an HDL cholesterol level filter, atriglyceride level filter, a blood pressure filter, an ASCVD riskfilter, a liver disease filter, and a risk enhancement factor filter.

The computer system runs survey results against a second series offilters that each generates a warning where the subject's survey resultsidentify a risk factor for OTC rosuvastatin. The second series offilters includes a kidney disease filter, an alcohol consumption filter,an adverse reaction filter, and a moderate drug interaction filter. Thecomputer system then prompts the subject to acknowledge or deny havingdiscussed any warning generated by the second series of filters with amedical professional (e.g., their physician).

The computer system then proceeds with a fulfillment process only when(i) none of the first series of filters was fired (ii) the subjectacknowledged that they discussed each warning issued in association withthe second series of filters that was fired. The computer system storesan indication of an initial order of the OTC rosuvastatin in a subjectprofile, and communicates an over the counter drug facts label for therosuvastatin pharmaceutical composition to the subject. Uponconfirmation from the subject that they have received and read the overthe counter drug facts label, the computer system authorizes provisionof the OTC rosuvastatin pharmaceutical composition to the subject.

Example 2

A computer system is prepared for qualifying a human subject fordelivery of an atorvastatin pharmaceutical composition (e.g., low-doseLIPITOR) over the counter to treat or prevent an atheroscleroticcardiovascular disease (e.g., by lowering cholesterol).

The computer system includes instructions for conducting a survey of thesubject, to obtain an age of the subject, a gender of the subject, ifthe subject is female, whether they are (i) pregnant, (ii)breastfeeding, or (iii) planning to become pregnant, a race of thesubject, whether the subject is taking one or more medications thatinteract with the statin pharmaceutical composition (e.g., cyclosporine,colchicine, lipid-lowering medications such as fibrates, and/or ananti-viral protease inhibitors), whether the subject has ever had anatherosclerotic cardiovascular event or had a heart procedure, whetherthe subject has a family history of premature ASCVD events, a totalcholesterol level of the subject, an LDL cholesterol level of thesubject, an HDL cholesterol level of the subject, a triglyceride levelof the subject, a systolic blood pressure of the subject, a diastolicblood pressure of the subject, whether the subject is taking amedication for high blood pressure, whether the subject has diabetes,whether the subject is a smoker, whether the subject has or has ever hadliver disease, whether the subject has or has ever had kidney disease,an alcohol consumption status of the subject, and whether the subjecthas ever has an adverse reaction to a cholesterol lowering medication.

The computer system runs survey results against a first series offilters that each prevents authorization for delivery of the OTCatorvastatin where the subject's survey results identify acontraindication for the OTC atorvastatin. The first series of filtersincludes an age filter, a pregnancy filter, a severe drug interactionfilter, a cardiac event filter, a total cholesterol level filter, an LDLcholesterol level filter, an HDL cholesterol level filter, atriglyceride level filter, a blood pressure filter, an ASCVD riskfilter, a liver disease filter, and a risk enhancement factor filter.

The computer system runs survey results against a second series offilters that each generates a warning where the subject's survey resultsidentify a risk factor for OTC atorvastatin. The second series offilters includes a kidney disease filter, an alcohol consumption filter,an adverse reaction filter, and a moderate drug interaction filter. Thecomputer system then prompts the subject to acknowledge or deny havingdiscussed any warning generated by the second series of filters with amedical professional (e.g., their physician).

The computer system then proceeds with a fulfillment process only when(i) none of the first series of filters was fired (ii) the subjectacknowledged that they discussed each warning issued in association withthe second series of filters that was fired. The computer system storesan indication of an initial order of the OTC atorvastatin in a subjectprofile, and communicates an over the counter drug facts label for theatorvastatin pharmaceutical composition to the subject. Uponconfirmation from the subject that they have received and read the overthe counter drug facts label, the computer system authorizes provisionof the OTC atorvastatin pharmaceutical composition to the subject.

Example 3

A computer system is prepared for qualifying a human subject fordelivery of a simvastatin pharmaceutical composition (e.g., low-doseZocor) over the counter to treat or prevent an atheroscleroticcardiovascular disease (e.g., by lowering cholesterol).

The computer system includes instructions for conducting a survey of thesubject, to obtain an age of the subject, a gender of the subject, ifthe subject is female, whether they are (i) pregnant, (ii)breastfeeding, or (iii) planning to become pregnant, a race of thesubject, whether the subject is taking one or more medications thatinteract with the statin pharmaceutical composition (e.g., cyclosporine,warfarin, colchicine, lipid-lowering medications such as fibrates,strong CYP3A4 inhibitors, and/or an anti-viral protease inhibitors),whether the subject has ever had an atherosclerotic cardiovascular eventor had a heart procedure, whether the subject has a family history ofpremature ASCVD events, a total cholesterol level of the subject, an LDLcholesterol level of the subject, an HDL cholesterol level of thesubject, a triglyceride level of the subject, a systolic blood pressureof the subject, a diastolic blood pressure of the subject, whether thesubject is taking a medication for high blood pressure, whether thesubject has diabetes, whether the subject is a smoker, whether thesubject has or has ever had liver disease, an alcohol consumption statusof the subject, and whether the subject has ever has an adverse reactionto a cholesterol lowering medication.

The computer system runs survey results against a first series offilters that each prevents authorization for delivery of the OTCsimvastatin where the subject's survey results identify acontraindication for the OTC simvastatin. The first series of filtersincludes an age filter, a pregnancy filter, a severe drug interactionfilter, a cardiac event filter, a total cholesterol level filter, an LDLcholesterol level filter, an HDL cholesterol level filter, atriglyceride level filter, a blood pressure filter, an ASCVD riskfilter, a liver disease filter, and a risk enhancement factor filter.

The computer system runs survey results against a second series offilters that each generates a warning where the subject's survey resultsidentify a risk factor for OTC simvastatin. The second series of filtersincludes an alcohol consumption filter, an adverse reaction filter, anda moderate drug interaction filter. The computer system then prompts thesubject to acknowledge or deny having discussed any warning generated bythe second series of filters with a medical professional (e.g., theirphysician).

The computer system then proceeds with a fulfillment process only when(i) none of the first series of filters was fired (ii) the subjectacknowledged that they discussed each warning issued in association withthe second series of filters that was fired. The computer system storesan indication of an initial order of the OTC simvastatin in a subjectprofile, and communicates an over the counter drug facts label for thesimvastatin pharmaceutical composition to the subject. Upon confirmationfrom the subject that they have received and read the over the counterdrug facts label, the computer system authorizes provision of the OTCsimvastatin pharmaceutical composition to the subject.

Example 4

A computer system is prepared for qualifying a human subject fordelivery of a pravastatin pharmaceutical composition (e.g., low-dosePRAVACHOL) over the counter to treat or prevent an atheroscleroticcardiovascular disease (e.g., by lowering cholesterol).

The computer system includes instructions for conducting a survey of thesubject, to obtain an age of the subject, a gender of the subject, ifthe subject is female, whether they are (i) pregnant, (ii)breastfeeding, or (iii) planning to become pregnant, a race of thesubject, whether the subject is taking one or more medications thatinteract with the statin pharmaceutical composition (e.g., cyclosporine,colchicine, and/or lipid-lowering medications such as fibrates,),whether the subject has ever had an atherosclerotic cardiovascular eventor had a heart procedure, whether the subject has a family history ofpremature ASCVD events, a total cholesterol level of the subject, an LDLcholesterol level of the subject, an HDL cholesterol level of thesubject, a triglyceride level of the subject, a systolic blood pressureof the subject, a diastolic blood pressure of the subject, whether thesubject is taking a medication for high blood pressure, whether thesubject has diabetes, whether the subject is a smoker, whether thesubject has or has ever had liver disease, an alcohol consumption statusof the subject, and whether the subject has ever has an adverse reactionto a cholesterol lowering medication.

The computer system runs survey results against a first series offilters that each prevents authorization for delivery of the OTCpravastatin where the subject's survey results identify acontraindication for the OTC pravastatin. The first series of filtersincludes an age filter, a pregnancy filter, a severe drug interactionfilter, a cardiac event filter, a total cholesterol level filter, an LDLcholesterol level filter, an HDL cholesterol level filter, atriglyceride level filter, a blood pressure filter, an ASCVD riskfilter, a liver disease filter, and a risk enhancement factor filter.

The computer system runs survey results against a second series offilters that each generates a warning where the subject's survey resultsidentify a risk factor for OTC pravastatin. The second series of filtersincludes a an alcohol consumption filter, an adverse reaction filter,and a moderate drug interaction filter. The computer system then promptsthe subject to acknowledge or deny having discussed any warninggenerated by the second series of filters with a medical professional(e.g., their physician).

The computer system then proceeds with a fulfillment process only when(i) none of the first series of filters was fired (ii) the subjectacknowledged that they discussed each warning issued in association withthe second series of filters that was fired. The computer system storesan indication of an initial order of the OTC pravastatin in a subjectprofile, and communicates an over the counter drug facts label for thepravastatin pharmaceutical composition to the subject. Upon confirmationfrom the subject that they have received and read the over the counterdrug facts label, the computer system authorizes provision of the OTCpravastatin pharmaceutical composition to the subject.

Example 5

A computer system is prepared for qualifying a human subject fordelivery of a fluvastatin pharmaceutical composition (e.g., low-doseLESCOL XL) over the counter to treat or prevent an atheroscleroticcardiovascular disease (e.g., by lowering cholesterol).

The computer system includes instructions for conducting a survey of thesubject, to obtain an age of the subject, a gender of the subject, ifthe subject is female, whether they are (i) pregnant, (ii)breastfeeding, or (iii) planning to become pregnant, a race of thesubject, whether the subject is taking one or more medications thatinteract with the statin pharmaceutical composition (e.g., cyclosporine,warfarin, colchicine, lipid-lowering medications such as fibrates, ananti-fungal agent such as fluconazole, and/or an anti-epileptic agentsuch as phenytoin), whether the subject has ever had an atheroscleroticcardiovascular event or had a heart procedure, whether the subject has afamily history of premature ASCVD events, a total cholesterol level ofthe subject, an LDL cholesterol level of the subject, an HDL cholesterollevel of the subject, a triglyceride level of the subject, a systolicblood pressure of the subject, a diastolic blood pressure of thesubject, whether the subject is taking a medication for high bloodpressure, whether the subject has diabetes, whether the subject is asmoker, whether the subject has or has ever had liver disease, whetherthe subject has or has ever had kidney disease, an alcohol consumptionstatus of the subject, whether the subject has thyroid problems, andwhether the subject has ever has an adverse reaction to a cholesterollowering medication.

The computer system runs survey results against a first series offilters that each prevents authorization for delivery of the OTCfluvastatin where the subject's survey results identify acontraindication for the OTC fluvastatin. The first series of filtersincludes an age filter, a pregnancy filter, a severe drug interactionfilter, a cardiac event filter, a total cholesterol level filter, an LDLcholesterol level filter, an HDL cholesterol level filter, atriglyceride level filter, a blood pressure filter, an ASCVD riskfilter, a liver disease filter, and a risk enhancement factor filter.

The computer system runs survey results against a second series offilters that each generates a warning where the subject's survey resultsidentify a risk factor for OTC fluvastatin. The second series of filtersincludes a kidney disease filter, an alcohol consumption filter, anadverse reaction filter, a thyroid problem filter, and a moderate druginteraction filter. The computer system then prompts the subject toacknowledge or deny having discussed any warning generated by the secondseries of filters with a medical professional (e.g., their physician).

The computer system then proceeds with a fulfillment process only when(i) none of the first series of filters was fired (ii) the subjectacknowledged that they discussed each warning issued in association withthe second series of filters that was fired. The computer system storesan indication of an initial order of the OTC fluvastatin in a subjectprofile, and communicates an over the counter drug facts label for thefluvastatin pharmaceutical composition to the subject. Upon confirmationfrom the subject that they have received and read the over the counterdrug facts label, the computer system authorizes provision of the OTCfluvastatin pharmaceutical composition to the subject.

Example 6

A computer system is prepared for qualifying a human subject fordelivery of a pitavastatin pharmaceutical composition (e.g., low-doseLIVALO) over the counter to treat or prevent an atheroscleroticcardiovascular disease (e.g., by lowering cholesterol).

The computer system includes instructions for conducting a survey of thesubject, to obtain an age of the subject, a gender of the subject, ifthe subject is female, whether they are (i) pregnant, (ii)breastfeeding, or (iii) planning to become pregnant, a race of thesubject, whether the subject is taking one or more medications thatinteract with the statin pharmaceutical composition (e.g., cyclosporine,colchicine, and/or lipid-lowering medications such as fibrates), whetherthe subject has ever had an atherosclerotic cardiovascular event or hada heart procedure, whether the subject has a family history of prematureASCVD events, a total cholesterol level of the subject, an LDLcholesterol level of the subject, an HDL cholesterol level of thesubject, a triglyceride level of the subject, a systolic blood pressureof the subject, a diastolic blood pressure of the subject, whether thesubject is taking a medication for high blood pressure, whether thesubject has diabetes, whether the subject is a smoker, whether thesubject has or has ever had liver disease, and whether the subject hasever has an adverse reaction to a cholesterol lowering medication.

The computer system runs survey results against a first series offilters that each prevents authorization for delivery of the OTCpitavastatin where the subject's survey results identify acontraindication for the OTC pitavastatin. The first series of filtersincludes an age filter, a pregnancy filter, a severe drug interactionfilter, a cardiac event filter, a total cholesterol level filter, an LDLcholesterol level filter, an HDL cholesterol level filter, atriglyceride level filter, a blood pressure filter, an ASCVD riskfilter, a liver disease filter, and a risk enhancement factor filter.

The computer system runs survey results against a second series offilters that each generates a warning where the subject's survey resultsidentify a risk factor for OTC pitavastatin. The second series offilters includes an adverse reaction filter and a moderate druginteraction filter. The computer system then prompts the subject toacknowledge or deny having discussed any warning generated by the secondseries of filters with a medical professional (e.g., their physician).

The computer system then proceeds with a fulfillment process only when(i) none of the first series of filters was fired (ii) the subjectacknowledged that they discussed each warning issued in association withthe second series of filters that was fired. The computer system storesan indication of an initial order of the OTC pitavastatin in a subjectprofile, and communicates an over the counter drug facts label for thepitavastatin pharmaceutical composition to the subject. Uponconfirmation from the subject that they have received and read the overthe counter drug facts label, the computer system authorizes provisionof the OTC pitavastatin pharmaceutical composition to the subject.

Example 7

A computer system is prepared for qualifying a human subject fordelivery of a lovastatin pharmaceutical composition (e.g., low-doseMEVACOR) over the counter to treat or prevent an atheroscleroticcardiovascular disease (e.g., by lowering cholesterol).

The computer system includes instructions for conducting a survey of thesubject, to obtain an age of the subject, a gender of the subject, ifthe subject is female, whether they are (i) pregnant, (ii)breastfeeding, or (iii) planning to become pregnant, a race of thesubject, whether the subject is taking one or more medications thatinteract with the statin pharmaceutical composition (e.g., cyclosporine,colchicine, lipid-lowering medications such as fibrates, strong CYP3Ainhibitors, and/or an anti-viral protease inhibitors), whether thesubject has ever had an atherosclerotic cardiovascular event or had aheart procedure, whether the subject has a family history of prematureASCVD events, a total cholesterol level of the subject, an LDLcholesterol level of the subject, an HDL cholesterol level of thesubject, a triglyceride level of the subject, a systolic blood pressureof the subject, a diastolic blood pressure of the subject, whether thesubject is taking a medication for high blood pressure, whether thesubject has diabetes, whether the subject is a smoker, whether thesubject has or has ever had liver disease, an alcohol consumption statusof the subject, and whether the subject has ever has an adverse reactionto a cholesterol lowering medication.

The computer system runs survey results against a first series offilters that each prevents authorization for delivery of the OTClovastatin where the subject's survey results identify acontraindication for the OTC lovastatin. The first series of filtersincludes an age filter, a pregnancy filter, a severe drug interactionfilter, a cardiac event filter, a total cholesterol level filter, an LDLcholesterol level filter, an HDL cholesterol level filter, atriglyceride level filter, a blood pressure filter, an ASCVD riskfilter, a liver disease filter, and a risk enhancement factor filter.

The computer system runs survey results against a second series offilters that each generates a warning where the subject's survey resultsidentify a risk factor for OTC lovastatin. The second series of filtersincludes an alcohol consumption filter, an adverse reaction filter, anda moderate drug interaction filter. The computer system then prompts thesubject to acknowledge or deny having discussed any warning generated bythe second series of filters with a medical professional (e.g., theirphysician).

The computer system then proceeds with a fulfillment process only when(i) none of the first series of filters was fired (ii) the subjectacknowledged that they discussed each warning issued in association withthe second series of filters that was fired. The computer system storesan indication of an initial order of the OTC lovastatin in a subjectprofile, and communicates an over the counter drug facts label for thelovastatin pharmaceutical composition to the subject. Upon confirmationfrom the subject that they have received and read the over the counterdrug facts label, the computer system authorizes provision of the OTClovastatin pharmaceutical composition to the subject.

REFERENCES CITED AND ALTERNATIVE EMBODIMENTS

All references cited herein are incorporated herein by reference intheir entirety and for all purposes to the same extent as if eachindividual publication or patent or patent application was specificallyand individually indicated to be incorporated by reference in itsentirety for all purposes.

The present invention can be implemented as a computer program productthat includes a computer program mechanism embedded in a non-transitorycomputer readable storage medium. For instance, the computer programproduct could contain the program modules shown in any combination ofFIGS. 1, 2, and 3 and/or described in FIG. 4 or 5. These program modulescan be stored on a CD-ROM, DVD, magnetic disk storage product, USB key,or any other non-transitory computer readable data or program storageproduct.

Many modifications and variations of this invention can be made withoutdeparting from its spirit and scope, as will be apparent to thoseskilled in the art. The specific embodiments described herein areoffered by way of example only. The embodiments were chosen anddescribed in order to best explain the principles of the invention andits practical applications, to thereby enable others skilled in the artto best utilize the invention and various embodiments with variousmodifications as are suited to the particular use contemplated. Theinvention is to be limited only by the terms of the appended claims,along with the full scope of equivalents to which such claims areentitled.

1. A method for qualifying a human subject for an over-the-counterprovision of a statin pharmaceutical composition, the method comprising:A) providing an assessment survey for obtaining a first information setfrom the subject, via a computer system having a processor programed toperform the assessment survey, the first information set comprising: asex of the subject, an age of the subject, when the subject is a female,whether the subject is pregnant or breastfeeding, whether the subject istaking one or more compositions that interact with the statinpharmaceutical composition, whether the subject has ever had a cardiacevent, a total cholesterol level of the subject, a low-densitylipoprotein (LDL) cholesterol level of the subject, a high-densitylipoprotein (HDL) cholesterol level of the subject, a triglyceride levelof the subject, a systolic blood pressure of the subject, a diastolicblood pressure of the subject, whether the subject has a livercondition, an alcohol consumption status of the subject, and whether thesubject has had an adverse reaction to a cholesterol loweringcomposition, B) applying an algorithm to the first information set, viaa computer system having a processor programed to perform the algorithm,wherein the algorithm: i) runs all or a portion of the first informationset against a first plurality of assessment filters, wherein the subjectis deemed not qualified for a statin treatment when a respective filterin the first plurality of assessment filters is fired and the method isterminated without authorizing provision of the statin pharmaceuticalcomposition to the subject, wherein the first plurality of assessmentfilters comprises: an age filter that is fired at least when the firstinformation set indicates the age of the subject fails to satisfy an agethreshold for receiving the statin pharmaceutical composition, when thesubject is a female, a pregnancy filter that is fired at least when thefirst information set indicates the subject is pregnant orbreastfeeding, a severe drug interaction filter that is fired at leastwhen the first information set indicates the subject is taking one ormore compositions that interact with the statin pharmaceuticalcomposition, wherein the one or more compositions are eachcontraindicated for co-administration with the statin pharmaceuticalcomposition, a cardiac event filter that is fired at least when thefirst information set indicates the subject has had a documented cardiacevent. a total cholesterol filter that is fired at least when the firstinformation set indicates the subject has a total cholesterol level thatfails to satisfy a ceiling total cholesterol level threshold, a LDLcholesterol filter that is fired at least when the first information setindicates the subject has a LDL cholesterol level that fails to satisfya ceiling LDL cholesterol level threshold, a HDL cholesterol filter thatis fired at least when the first information set indicates the subjecthas a HDL cholesterol level that fails to satisfy a ceiling HDLcholesterol level threshold, a triglyceride filter that is fired atleast when the first information set indicates the subject has atriglyceride level that fails to satisfy a ceiling triglyceride levelthreshold, a blood pressure filter that is fired at least when the firstinformation set indicates (i) the systolic blood pressure of the subjectfails to satisfy a ceiling systolic blood pressure threshold or (ii) thediastolic blood pressure of the subject fails to satisfy a ceilingdiastolic blood pressure threshold, an atherosclerotic cardiovasculardisease (ASCVD) risk pooled cohort equation filter that is fired atleast when an ASCVD risk derived from the first information setindicates the ASCVD risk of the subject fails to satisfy a ceiling ASCVDrisk threshold, and a liver condition filter that is fired at least whenthe first information set indicates the subject has a liver condition;ii) runs all or a portion of the first information set against a secondplurality of assessment filters, wherein, when a respective filter inthe second plurality of assessment filters is fired, the subject isprovided with a warning corresponding to the respective filter, andwherein the second plurality of assessment filters comprises: an alcoholconsumption filter that is fired at least when the alcohol consumptionstatus of the subject in the first information set fails to satisfy aceiling alcohol consumption threshold, a first adverse reaction filterthat is fired at least when the first information set indicates thesubject has had an adverse reaction to a cholesterol-lowering drug, anda moderate drug interaction filter that is fired at least when the firstinformation set indicates the subject is taking one or more compositionsthat interact with the statin pharmaceutical composition, wherein theone or more compositions are each associated with a warning, but are notcontraindicated, for co-administration with the statin pharmaceuticalcomposition; and iii) obtains acknowledgment from the subject confirmingthat the subject has discussed the risk factor associated with eachwarning issued to the subject by any filter in the second plurality ofassessment filters with a physician; and iv) proceeds with a fulfillmentprocess when (a) no filter in the first plurality of assessment filtershas been fired and (b) the subject has acknowledged each warningassociated with each filter in the second plurality of assessmentfilters that was fired, wherein the fulfillment process comprises:storing an indication in a subject profile of an initial order for thestatin pharmaceutical composition, communicating an over the counterdrug facts label for the statin pharmaceutical composition to thesubject, and authorizing, upon confirmation from the subject that theover the counter drug facts label has been received and read, provisionof the statin pharmaceutical composition to the subject; and C)administering, after authorization of the provision, the statinpharmaceutical composition to the subject. 2-15. (canceled)
 16. Themethod of claim 1, wherein the cardiac event filter is fired when thefirst information set indicates that the subject is a young male withouta familial history of premature heart disease.
 17. (canceled)
 18. Themethod of claim 1, wherein the total cholesterol filter is fired whenthe first information set indicates the subject has a total cholesterollevel that fails to satisfy a total cholesterol level threshold. 19-20.(canceled)
 21. The method of claim 1, wherein the LDL cholesterol filteris fired when the first information set indicates the subject has a LDLcholesterol level that fails to satisfy a LDL cholesterol levelthreshold. 22-28. (canceled)
 29. The method of claim 1, wherein theblood pressure filter is fired when the first information set indicatesthe subject has a systolic blood pressure that fails to satisfy asystolic blood pressure threshold. 30-31. (canceled)
 32. The method ofclaim 1, wherein: the first information set further comprises: a race ofthe subject, whether the subject is taking a high blood pressuretreatment, a diabetes status of the subject, and a smoking status of thesubject; and the ASCVD risk pooled cohort equation filter incorporatesthe age of the subject, the gender of the subject, the race of thesubject, the total cholesterol level of the subject, the LDL cholesterollevel of the subject, the HDL cholesterol level of the subject, thetriglyceride level of the subject, the systolic blood pressure of thesubject, the diastolic blood pressure of the subject, whether thesubject is taking a medication for hypertension, the diabetes status ofthe subject, and the smoking status of the subject to derive a risk forASCVD. 33-34. (canceled)
 35. The method of claim 1, wherein the ASCVDrisk pooled cohort equation filter is fired when the first informationset indicates the subject has an ASCVD risk that fails to satisfy anASCVD risk threshold.
 36. (canceled)
 37. The method of claim 35, whereinthe algorithm bypasses firing the ASCVD risk pooled cohort equationfilter when the first information set indicates: (i) the subject has anASCVD risk that fails to satisfy the ASCVD risk threshold, (ii) thesubject has diabetes, and (iii) the age of the subject satisfies a firstceiling diabetes age threshold for receiving the statin pharmaceuticalcomposition.
 38. (canceled)
 39. The method of claim 1, wherein the ASCVDrisk pooled cohort equation filter is fired when the first informationset indicates: (i) the subject has diabetes, and (ii) the age of thesubject does not satisfy a second ceiling diabetes age threshold forreceiving the statin pharmaceutical composition.
 40. (canceled)
 41. Themethod of claim 1, wherein the algorithm bypasses the ASCVD risk pooledcohort equation filter when the first information set indicates when thesubject is a younger male.
 42. The method of claim 41, wherein thealgorithm bypasses the total cholesterol filter when the firstinformation set indicates when the subject is a younger male.
 43. Themethod of claim 41, wherein the algorithm bypasses the HDL cholesterolfilter when the first information set indicates when the subject is ayounger male.
 44. The method of claim 41, wherein the algorithm bypassesthe blood pressure filter when the first information set indicates whenthe subject is a younger male.
 45. The method of claim 1, wherein: thestatin pharmaceutical composition comprises rosuvastatin as an activeingredient, and the second plurality of assessment filters includes akidney disorder filter that is fired at least when the first informationset indicates that the subject has kidney disease.
 46. The method ofclaim 1, wherein: the statin pharmaceutical composition comprises anactive ingredient selected from the group consisting of fluvastatin,atorvastatin, and pitavastatin, and the second plurality of filtersincludes a kidney disorder filter that is fired at least when the firstinformation set indicates that the subject has kidney disease. 47-48.(canceled)
 49. The method of claim 1, wherein the first plurality ofassessment filters includes a risk enhancing factor filter that is firedunless the first information set indicates that the subject has at leastone of a plurality of risk enhancing factors for high cholesterol.50-55. (canceled)
 56. The method of claim 49, wherein the plurality ofrisk enhancing factors that prevent firing of the risk enhancing factorfilter comprises South Asian descent, a familial history of prematureheart disease, a LDL cholesterol level of at least 160 mg/dL, atriglyceride level of at least 175 mg/dL, an inflammatory disease,preeclampsia, premature menopause, a C-Reactive Protein (CRP) level ofat least 2 mg/L, coronary artery calcium, and metabolic syndrome. 57.The method of claim 56, wherein the subject is deemed to have themetabolic syndrome when the first information set indicates the subjecthas: (i) a HDL cholesterol level of less than 40 mg/dL, (ii) atriglyceride level of greater than 150 mg/dL, and (iii) a systolic bloodpressure of at least 130 mmHg, a diastolic blood pressure of at least 85mmHg, or a current blood pressure medication regimen when the subjecthas a systolic blood pressure of less than 130 mmHg and a diastolicblood pressure of less than 85 mmHg.
 58. The method of claim 57, whereinthe subject is deemed to have the metabolic syndrome when the firstinformation set indicates the subject has: (A) a waist circumference ofat least 35 inches for a female or at least 40 inches for a male, and(B) at least two of: (i) a HDL cholesterol level of less than 40 mg/dL,(ii) a triglyceride level of greater than 150 mg/dL, and (iii) asystolic blood pressure of at least 130 mmHg, a diastolic blood pressureof at least 85 mmHg, or a current blood pressure medication regimen whenthe subject has a systolic blood pressure of less than 130 mmHg and adiastolic blood pressure of less than 85 mmHg. 59-76. (canceled)
 77. Themethod of claim 1, wherein, upon confirmation from the subject that theover the counter drug facts label has been received and read, thesubject is authorized for provision of a dosage of from 2.5 mg to 15 mgof rosuvastatin per day.
 78. The method of claim 1, wherein, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, the subject is authorized for provision of adosage of 5 mg of rosuvastatin per day.
 79. The method of claim 1,wherein, upon confirmation from the subject that the over the counterdrug facts label has been received and read, the subject is authorizedfor provision of a dosage of from 20 mg to 40 mg of fluvastatin per day.80. The method of claim 1, wherein, upon confirmation from the subjectthat the over the counter drug facts label has been received and read,the subject is authorized for provision of a dosage of from 10 mg to 40mg of atorvastatin per day.
 81. The method of claim 1, wherein, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, the subject is authorized for provision of adosage of from 1 mg to 4 mg of pitavastatin per day.
 82. The method ofclaim 1, wherein, upon confirmation from the subject that the over thecounter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 10 mg to 40 mg oflovastatin per day.
 83. The method of claim 1, wherein, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, the subject is authorized for provision of adosage of from 10 mg to 40 mg of pravastatin per day.
 84. The method ofclaim 1, wherein, upon confirmation from the subject that the over thecounter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 5 mg to 20 mg ofsimvastatin per day. 85-89. (canceled)